LIVE BLOG: Orthopaedic and Rehabilitation Devices Panel

Orthopedics Today live blogged the FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting on the classification of cervical pedicle and lateral mass screw spinal systems on Friday, Sept. 21.

3:01 pm: Panel adjourns.

2:55 pm: New said the screws should be considered class II devices. Crawford concurred noting the potential benefits for pediatric patients. Blumenstein said he is disappointed with the number of comparative trials, but agrees with class II categorization. Rao said, “when done appropriately, with appropriate training” the implant is safe and should be categorized as a class II device. O’Brien agreed and said the FDA should consider the concerns expressed in the consensus.

2:51 pm: Kelly opens the floor for summations.

2:40 pm: Panel is in agreement that the proposed requirements of using cross-sectional imaging to assist in proper screw placement is necessary and noted concerns about the precise indications for additional studies.

2:38 pm: Panel comments on the FDA’s proposed requirement of using cross-sectional imaging (i.e., CT and/or MRI) to assist in proper screw placement, given the unique anatomic features of the cervical spine. Diaz said he is concerned about CT scans and, specifically, FLASH CT radiation.

2:37 pm: Panel agrees with special controls for the assessment of risks in posterior cervical screw fixation, but notes there are concerns for increased surgical volume and quantification for bone mass purchase in elderly patients.

2:34 pm: Rao agreed that all the screws and devices used in the posterior cervical spine are reasonably safe when used in the appropriate fashion for the appropriate indications, but holds that there should be a way to distinguish between pedicle screws C3 to C6 and lateral mass C3 to C6 for labeling.

2:33 pm: Panel discusses the adequacy of the proposed special controls in the assessment of the risks associated with posterior cervical screw fixation systems.

2:32 pm: Panel concludes the completeness of the risks is reasonable.

2:28 pm: Rao said nerve root deficit caused by foraminal stenosis is a risk. Heller said monitoring may not catch this. Kirkpatrick asked if this would resolve with hardware removal. Heller noted that a foraminotomy was performed in this case.

2:24 pm: Kirkpatrick said, “It’s not intrinsic to the implants we are discussing today, but some patients may have hypersensitivity to metal alloys.”

2:21 pm: Panelists comment on the completeness of the identified risks to health.

2:20 pm: Panel concludes there are risks associated with the presence of vertebral arteries, but there is also anatomic variance that may present increased risk.

2:19 pm: New said axial imaging with CT and MRI is important for the evaluation of cases, including lateral masses and small pedicles. The patients need to be assessed by the surgeon preoperatively, he said.

2:18 pm: Panel discusses other risks that may be present in the cervical spine other than the risks associated with the presence of the vertebral arteries.

2:17 pm: Panel concludes that posterior screw fixation is adequate for patients in whom fusion would not be expected.

2:16 pm: New notes that other than tumor cases, if someone wants to use the devices to replicate motion, then they would have to conduct a controlled trial.

2:14 pm: Panel discusses the adequacy of the documented literature in the treatment of patients with posterior cervical screw fixation techniques (limited to tumor), in whom a fusion would not be expected.

2:13 pm: The panel concludes that there is reasonable literature for the pediatric population.

2:11 pm: Crawford said the pediatric population cross-section must be adequate. MRI and robotics are “areas of ensuring safety in the trajectory and basic anatomy,” he said.

2:10 pm: Panel discusses the adequacy of the documented literature, including a pediatric population (21 years of age or younger), for treatment with posterior cervical screw fixation systems.

2:09 pm: The panel concludes that the screw trajectories are reasonable and certain indications with regards to other devices should be added.

2:04 pm: Panel confirms the adequacy of the proposed indications, but other issues need further discussion.

2:01 pm: Lehman asked if the definition as the FDA proposed includes intralaminar or pars screws of C2 and C7. Panelist Fernando G. Diaz, MD, PhD, neurosurgeon at Michigan Head & Spine Institute, and professor and chairman of the Neurological Surgery Department, Oakland University School of Medicine and William Beaumont Hospitals, said C3 to C6 falls within the scope of the individual practice and is not for classification purposes.

1:57 pm: The panel discusses the overall adequacy of the proposed indications for use for posterior cervical screw fixation systems.

1:55 pm: In response to the second question, the panel believes there adequate evidence to support the effectiveness of the devices.

1:51 pm: Trier noted that “there are a number of literature reviews that have been done,” which came to the same conclusion — that the devices are effective and there is a low rate of complications.

1:49 am: Panelist Carl N. Graf, MD, FAAOS, orthopedic spinal surgeon at the Illinois Spine Institute, said there is enough evidence to support effectiveness. Panelist Brent A. Blumenstein, PhD, principal consultant of Trial Architecture Consulting, said the evidence is “a result of incremental steps from people who do the work, but we don’t know that it’s that much better” and noted a lack of long-term comparative outcome data “with respect to short-term adverse events.”

1:48 pm: The panel addresses the second question: Please comment on the adequacy of the available scientific evidence in supporting a reasonable assurance of effectiveness in using cervical screw fixation systems for the treatment of the proposed, indicated population.

1:47 pm: Kelly concluded that the panel generally believes there is adequate scientific evidence of the safety of the cervical screw fixation systems.

1:39 pm: Kirkpatrick commented that one article questioned safety and includes “significantly complicated cases and has no trauma.” He said there is a preponderance of evidence to allow the screws to be classified as class II devices.

1:32 pm: The panel’s patient representative Joseph P. O’Brien, MBA, president and chief executive officer of the National Scoliosis Foundation, said the device itself seems safe, but noted that others have shown different outcomes. The best centers may show the best results.

“There’s a disconnect between published data and postmarket adverse events,” O’Brien said.

1:29 pm: Rue said there is significant data but limited long-term data on the use of the devices in the pediatric population. Crawford highlighted a state of transition in which the pediatric population is approached differently with more aggressive treatments not used in the past. He noted that pedicle screws have been a “tremendous benefit” in pediatric cases that needed halos or had skin issues.

1:27 pm: Panel discusses the first deliberation question: Please comment on the adequacy of the available scientific evidence in supporting a reasonable assurance of safety in using cervical screw fixation systems for treating the proposed, indicated population.

1:26 pm: Kelly closes the open, public hearing portion of the meeting and opens the floor to deliberations.

1:15 pm: “Our concerns are that we have as much data as possible to determine which products are the safest,” Zuckerman said. “At this point, we don’t know what they are. We do know there are some studies showing a much higher failure rate. I ask you [to] urge the FDA to provide better data.” She cited a lack of data for specific devices and questioned whether there are safer specific devices within this class of devices.

1:13 pm: “If the FDA considers these products a moderate risk device going through the 510(k) process, [then] not only will they not require clinical trials, [but] they will not have premarket inspections,” Zuckerman said.

1:11 pm: Zuckerman: The FDA and OSMA reviews did not discuss a 4-year study of 84 patients with 33 complications. She noted that the researchers found that 13% of patients had neurological damage after surgery, with palsy cited as the most common injury. Another 13% had implant failures. If 13% is considered low risk, then it has to be “looked at in terms of the benefits,” she said. Patients who benefit have to be “counterbalanced by patients being harmed,” she said.

1:08 pm: Diana Zuckerman, PhD, president of the National Research Center for Women & Families, discusses her group’s concerns about the lack of long-term data on the devices and information about specific products. She questioned whether the products should be considered moderate risk or high risk based on the quality of the product and whether patients are harmed.

1:02 pm: In a database study, the CSRS found a 97% fusion rate in patients; 1% had nerve root injuries and there were no cases of vertebral artery injury. Riley said that based on the systematic review, the CSRS holds that re-classification to Class II is justified and the evidence also supports lateral mass screw fixation for tumor cases, which the panel excluded. “The tumor resection is a challenging procedure and requires stable constructs,” Riley said.

12:55 pm: Representing the Cervical Spine and Research Society (CSRS), Lee H. Riley III, MD, associate professor and division chief for Spine at the Department of Orthopaedic Surgery at Johns Hopkins University, said lateral mass and pedicle screws can be used in posterior or in combination with anterior surgery with a separate incision. The CSRS is concerned about inadequate education leading to increased complications.

12:54 pm: Immediate past president of NASS, Gregory Przybylski, MD, professor of neurosurgery at Seton Hall University and director of Neurosurgery at the New Jersey Neuroscience Institute at JFK Medical Center, said pedicle and lateral mass screws are comparable to other pedicle screw fixation techniques. He said the screws are “clinically justified” as class II devices and have been studied in a variety of clinical settings, including trauma, neoplasm, degenerative cases and myelopathy. He also said the screws are as safe and effective as the predicate devices.

12:49 pm: Representing the Congress to Neurologic Surgeons and American Association of Neurological Surgeons (AANS), William C. Welch, MD, FAANS, FACS, FICS, chair of the Department of Neurosurgery at Pennsylvania Hospital and vice-chair of the Department of Neurosurgery at Perelman School of Medicine at the University of Pennsylvania, said that speaking from experience doing 1,000 cases in 20 years, he and AANS and the Congress to Neurologic surgeons feel “posterior element fixation devices” are safe, effective and improve surgical outcomes.

“In summary, we strongly support the classification of these posterior element fixation devices as adjunct to fusion and we strongly recommend that they be classified as class II status,” Welch said.

12:45 pm: Anderson: Root injuries are rarely seen with lateral mass fracture reduction caused by root deficits. There is a 1% risk of root injuries and 0% for vertebral injuries. There is a higher complication rate of vertebral artery injuries with pedicle screws.

12:40 pm: Anderson said the main structures at risk are the vertebral artery and exiting nerve root, so he cautioned that surgeons should select screws appropriately. When the screw direction is up and outward, he said these structures can be avoided, so training is necessary.

12:38 pm: Representing the American Academy of Orthopaedic Surgeons, Paul A. Anderson, MD, professor of Orthopedic Surgery University of Wisconsin, Madison, reviews the surgical indications and gives his analysis of the safety and efficacy of the devices.

12:33 pm: Todd J. Albert, MD, president of Rothman Institute, speaks on behalf of the Scoliosis Research Society. He sees the indications of these instruments for trauma, degenerative cases, deformity correction and neoplasia.

“You cannot correct these deformities without the use of bone screws in the cervicothoracic spine,” Albert said. “Posterior cervical screws are safe and effective,” he said and noted that changing the classification will improve the surgical results.

12:30 pm: Panel reconvenes. Kelly commences the open, public hearing portion of the meeting.

11:45 am: The panel is on lunch break and will reconvene at 12:30 pm.

11:40 am: The panel’s consumer representative Karen R. Rue, RNC, MBA, director and owner of Acadiana Office of Griswold Home Care, said training is part of safety, and proposed that the one death reported would not have occurred if proper training was obtained.

11:28 am: Ghanayem noted that whether the discussion is about lateral mass or pedicle screws, the risk is low with both procedures.

11:26 am: Rao noted that much of the discussion centers on grouping multiple spinal levels. “But we’ve been doing these procedures for the last 20 years, and the risks have been low,” Rao said. He asked if the panelists should continue grouping levels to ensure that surgeons are properly trained.

11:23 am: Melkerson noted this is a classification for a pre-amendment device, and those manufacturers who want to add indications for uses in terms of marketing need to petition the FDA under the 510(k) process.

11:22 am: Crawford asked if language could be included for use in growth modulation without fusion in pediatric patients.

11:19 am: Starowicz said the intent of the petition is only for fusion — not motion.

11:16 am: Heller said the spine and spinal cord must be protected when radiation therapies are used, which he noted may kill the bone graft. However, he said surgeons may discuss the option of elective fusion with patients a few years after the procedure. Therefore, labeling is needed to “make that choice.”

11:12 am: Panelist Alvin H. Crawford, MD, FACS, professor of the Crawford Spine Center and professor, Division of Pediatric Surgery at Cincinnati Children’s Hospital Medical Center, said that this specialty is pediatric spine and noted, “There’s a lot of data, but not a lot of information.” He said that the key issues are application and training.

11:08 am: Panelist Kent C. New, MD, PhD, a neurosurgeon at St. Vincent’s Spine & Brain Institute, said that most questions revolve around the “distinction of device and the technique.”

11:00 am: Mark N. Melkerson, director of the Division of Surgical, Orthopedic and Restorative Devices, Office of Device Evaluation, Center for Devices and Radiological Health, noted that changes in surgeon practices may increase the number of procedures that use these screws, and the monitoring adverse event profiles already exist.

10:55 am: Kelly notes that training is part of the safety issue. “It has to be included in the overall safety package,” he said.

10:47 am: Devlin answers that the regulatory ruling needs to be discussed.

10:46 am: Panel member John S. Kirkpatrick, MD, chair of the Department of Orthopaedic Surgery and Rehabilitation at the University of Florida, asks if there is room in the regulatory structure to use skeletal maturity and size instead of specific ages for the pediatric population.

10:42 am: Hill answers that the testing is specific to the bone-implant interface and FDA does not require that companies directly address loosening at the bone-implant interface. Rao suggested the FDA revisit this issue using cyclical mechanical load testing.

10:42 am: Hill answers that the testing is specific to the bone-implant interface and the FDA does not require that companies directly address loosening at the bone-implant interface. Rao suggested the FDA revisit this issue using cyclical mechanical load testing.

10:38 am: Rao to Hill: “The FDA has felt mechanical testing is not required for loosening. Could you elaborate as to your thought process behind the exclusion of mechanical testing for implant loosening? Would a difference in screw design with lower incidence of screw loosening not be tested?”

10:35 am: Panelists question FDA representatives about the intention for use down to T3 levels, who determines proper surgeon training and what it entails.

10:24 am: Hill: The first proposed special control is labeling, which should list indications and warnings and include prescription labels. The second proposed control is that surgeons who use the devices be properly trained through courses offered by spinal societies and manufacturers. The other controls include material standards, biocompatibility, sterilization validation and mechanical testing.

10:19 am: Genevieve A. Hill, BS, biomedical engineer for the FDA, discusses the health risks from pedicle and lateral screws and proposed special controls to mitigate these risks.

10:13: Devlin: The third area that requires further discussion is the use of posterior cervical screw constructs in the absence of fusion.

10:12 am: The second area that merits additional discussion is posterior cervical screw fixation in the pediatric population younger than 21 years, Devlin said. The FDA conducted a review of literature of posterior screw constructs between 1999 and 2012.

10:10 am: Devlin said that a C2 translaminar screw trajectory provides less risk of vertebral artery injury, but the C1-C2 transarticular screw trajectory carries a risk for vertebral artery injury.

10:08 am: Devlin said the FDA has identified three areas that merit additional analysis. One of these areas includes screw trajectories with a focus on the C2 spinal level.

10:02 am: Vincent J. Devlin, MD, orthopedic spine surgeon and medical officer in the FDA’s Orthopedic Spinal Branch, Division of Surgical, Orthopedic and Restorative Devices, presents the clinical background and literature review related to cervical screw use. The FDA is addressing screws with longitudinal members, he said.

10:00 am: Rhim notes that occipito-cervico-thoraci​c (OCT) systems were cleared by the 510(k) process as class II devices, but only for use in the occiput and thoracic areas.

9:56 am: Rhim notes that the regulatory history of pedicle screw systems dates back to 1990s. Panel meetings in 1993 and 1994 did not discuss screws in the cervical spine or in skeletally immature patients.

9:52 am: The FDA presentation begins. Caroline Rhim, PhD, biomedical engineer in the FDA’s Orthopedic Spinal Branch, Division of Surgical, Orthopedic and Restorative Devices, addresses the OSMA petition. She discusses the device and provides the clinical background, literature review and information on the risks to patient health and presents proposed special controls to mitigate these risks.

9:35 am: The panel breaks until 9:50 am.

9:32 am: Ronald A. Lehman Jr, MD, LTC, MC, USA, of the Department of Orthopaedic Surgery and Rehabilitation at Walter Reed National Military Medical Center., asks Heller to explain the placement of screws vs. hooks and wires. Heller said there is more of a margin of error with hooks, wires or cables.

9:30 am: Heller responds that the patient experience would be different than motion segments in the postoperative period. The literature shows overall effectiveness and safety is enhanced with newer rather than the older techniques. Heller notes it is difficult to suggest to patients that these are equal opportunities.

9:29 am: Trier asks Heller, “In your comment in response to equipoise, you were responding you would have difficulty getting IRB approval for clinical trial. Would that be based on the fact that the two devices in a study would be seen as having a better safety and effectiveness profile compared to hooks and screws?”

9:26 am: Panel member Kathy Trier, PhD, vice president of clinical and regulatory affairs for Corin USA Limited, asks Starowicz about the special controls and ASTM standards. “Could you describe, just briefly, in 510(k)s, if these screws are classified as class II, what is the level of detail that is submitted to FDA?”

9:23 am: Ghanayem notes that, as a former continuing medical education head for the North American Spine Society (NASS), he wants reclassification to include pedicle screws to ensure that residents can be taught salvage/bailout techniques. “We can't send them into the OR partially trained,” he said.

9:20 am: Panelist Rajkumar D. Rao, MD, professor of orthopaedic surgery at the Medical College of Wisconsin, asks Starowicz if, with the change in reclassification of the devices, the industry or her specific employer has carried out any financial analyses with more or less revenues, because Rao said there are additional burdens that classification of a device imposes, including manufacturing, labeling and training.

9:05 am: The sponsor concludes its presentation.

9:04 am: OSMA holds that class II is the appropriate classification for the devices.

9:01 am: OSMA recommends quality system regulation, labeling, recordkeeping and reporting related to adverse events and recalls. OSMA also recommends special controls to mitigate risks such as performance standards, training and labeling information. Similar controls are already outlined for other spinal systems. Compliance will provide reasonable assurance of the safety of the materials used in the devices. These materials have an established safety profile in orthopedic implants. OSMA also notes that screws need to be characterized according to well-established testing standards.

8:59 am: Sharon Starowicz, president of OSMA, reviews the proposed regulatory controls of screws for cervical use.

8:58 am: Reclassification of the devices will optimize the learning curve for residents and end dependence on wiring, Ghanayem said.

8:55 am: The reoperation rate with wiring was 5.8%. The rate with pedicle and lateral mass screws was 3% using information from an FDA database. The “worse case scenario” for anterior devices was 0.17% and 3.71% for posterior devices, Ghanayem said.

8:54 am: Other adverse event rates were, “one-tenth of a percent when present at all,” Ghanayem said. Death related to procedures was 0.1% and up to 2.8% for lateral mass screws. He noted that the “big elephant in the room” is vertebral artery injuries.

8:52 am: Mean accuracy of placement was 92%. Ghanayem noted that constrained devices outperformed nonconstrained devices. Rates of anchored adverse events were low.

8:50 am: According to Ghanayem, 32 postoperative CT scans of 2,000 patients with 8,000 screws and two comparative studies found satisfactory screw insertion for pedicle and lateral mass screws in 94%.

8:48 am: Screw-rod techniques have higher rate of neurologic preservation and protection than screw-plate techniques, according to Ghanayem.

8:46 am: Trauma cases had the greatest use of lateral and pedicle screws, according to Ghanayem. Tumor cases used more pedicle screws due to more cases of instability.

8:44 am: Ghanayem presents findings of studies that involved wiring techniques. Fifty-one articles involved lateral mass and pedicle screws. There were 2,967 patients.

8:43 am: Alexander Ghanayem, MD, FAAOS, professor of orthopaedic surgery and rehabilitation and chief of the Division of Spine Surgery at Loyola University, discusses the published literature on the safety of lateral mass and cervical pedicle screws.

8:40 am: We wish we could teach salvage techniques with boutique options to our students, but with classification “in limbo,” we are not able to do that, Heller said.

8:39 am: Pedicle screw strength is two-fold stronger, but comes with anatomical constraints and potential risks, Heller said.

8:38 am: Research from cadaver studies show that error rates should be less than 4% for lateral mass plating, Heller said.

8:37 am: According to Heller, wires do not hold rods well and could cause new spinal cord compression.

8:31 am: “Twenty years ago, we asked ourselves, ‘Why plates or screws?’ [It was an] innovation at the time. [It] allows us to rapidly mobilize without the encumbrance of halos and return [patients] to life as best they can,” Heller said.

8:30 am: “Wire works, but it’s not infallible. We find ourselves challenged with situations where surgical trauma required removal of laminae,” Heller said.

8:28 am: John G. Heller, MD, professor of orthopaedic surgery at Emory Spine Center, discusses the history of screws.

8:26 am: OSMA representative says other similar class II devices have been cleared by the FDA.

8:24 am: OSMA representative notes these systems are intended to provide immobility and stability of spinal segments as an adjunct to fusion during bone graft healing.

8:20 am: OSMA seeks certification of orthopedic cervical and lateral mass screws as class II devices.

8:19 am: Kelly proceeds to the presentation from the Orthopedic Surgical Manufacturers' Association (OSMA).

8:13 am: LCDR Sara Anderson, USPHS, designated federal officer of the FDA, makes conflict of interest statement. All members and consultants are special members of other agencies and are subject to conflict of interest laws.

8:08 am: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Chairperson John D. Kelly IV, MD, associate professor of clinical orthopaedic surgery at the University of Pennsylvania, commences the meeting discussing recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws.