MAUDE Adverse Event Report: NUVASIVE INC. SIMPLIFY CERVICAL ARTIFICIAL DISC; PROTHESIS INTERVERTEBRAL DISC

Model Number	SM-4
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Neck Pain (2433); Limb Pain (4836)
Date of Event	03/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a ct scan was done due to no relief from continued neck and shoulder pain the disc slipped out of place again at c6/7 as well as the disc at c5/6 and will have to have surgery again.On (b)(6) 2022 a revision took place removing both migrated discs at c5/6 and c6/7 and replaced with allograft for fusion.(1 of 2 200068992).
Additional Manufacturer Narrative
No explanted device has been returned to nuvasive as they were removed and retained by the patient.One lateral radiograph was obtained with no dated reference, review of the radiograph identified the disc at the c5-c6 level is located within the disc space, slightly posterior to the midpoint and the motion segment is in slight kyphosis.Additionally the implant at the c6-c7 level is positioned at the posterior extreme of the disc space and the motion segment is in kyphosis with the anterior c6 and c7 endplates almost touching.No subsidence or additional pathologies observed.Review of historical data found no other similarly reported events.With the information provided no definitive root cause could be determined although implant selection and placement as well as postoperative physical activity and continuation of pathology are likely cause or contributors.No additional investigation can be completed at this time, should additional information become available a follow up report will be completed.Manufacturing review: review of the device history records of all devices notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "warnings: simplify® cervical artificial disc should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone hands-on training in the use of this device.Only surgeons who are familiar with simplify® cervical artificial disc components, instruments, procedure, clinical applications, biomechanics, adverse events (aes), and risks associated with simplify® cervical artificial disc should use this device.A lack of adequate experience and/or training may lead to a higher incidence of aes, including neurological complications.Correct selection of the appropriate implant size and correct placement of simplify® cervical artificial disc are essential to ensure proper performance and functioning of the device.Information regarding implant size selection and correct implant placement is provided in the simplify® cervical artificial disc surgical technique guide.Removal of the disc may be required during device re-positioning or for other surgical considerations.This process could cause damage that is not visually apparent¿if a disc is removed during the implantation procedure, a new device should be implanted in its place.Due to the proximity of vascular structures, neurological structures, and major organ systems to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurological damage and/or injury to adjacent organs with the use of simplify® cervical artificial disc.Care must be taken to identify and protect these structures." "preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all co-morbidities, past and present medications, previous treatments, etc.Upon reviewing all relevant information, the surgeon must determine whether a bone density (dexa) scan is prudent.If dexa is performed, the patient should not receive the device if the dexa bone mineral density t-score is <-1.5, as the patient may be osteoporotic or osteopenia.Patient selection is extremely important.In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient¿s occupation or activity level; a condition of senility, mental illness, alcoholism or drug abuse; certain degenerative diseases that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased, and medical conditions that may affect postoperative management, such as alzheimer¿s disease and emphysema.The patient should be informed of the potential adverse effects (risks/complications) contained in this insert (see safety results / aes).Information on the proper implant site preparation, implant size selection, and the use of surgical instrumentation for the simplify® cervical artificial disc is provided in the surgical technique guide and should be reviewed prior to surgery.Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery.Correct selection of the appropriate implant sizes is extremely important to assure the placement and function of the disc.The procedure should not take place if the appropriate range of sizes are not available." "intraoperative: ensure simplify® cervical artificial disc does not come into contact with hard objects that may damage the implant and render the implant functionally unreliable.Visual inspection of the prosthesis is recommended prior to implanting the device.If any part of the device appears damaged or not fully assembled, do not use.Take care not to over-distract the disc space.Excessive removal of endplate cortical bone may result in sub-optimal outcomes.Surgical implants must never be re-used or re-implanted.Even though the device appears undamaged, it may have small defects and internal stress patterns that may lead to early breakage." "postoperative: patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device.Heavy lifting (greater than 20lbs) should be avoided for 6 weeks, and impact sports should be avoided for 3 months." "potential adverse effects of device on health: below is a list of the potential adverse effects (e.G., complications) identified from the simplify® cervical artificial disc clinical study results, approved device labeling for other cervical total disc replacement devices, and published scientific literature including: (1) those associated with any general surgical procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device, including the simplify® cervical artificial disc.In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms or may cause worsening of symptoms.Additional surgery may be required to correct some of the adverse effects." "anterior cervical surgical risks are, but may not be limited to: injury or damage to the trachea, esophagus, nerves or blood vessels.Arm weakness or numbness.Nerve root injury.Unresolved pain." "risks specific to cervical artificial discs, including the simplify® cervical artificial disc, are but may not be limited to: implant failure, device migration, device subsidence, placement difficulties, device malposition, improper device sizing, disc space collapse, kyphosis or hyper-extension, loss of flexibility, nerve injury, paralysis or weakness that is temporary or permanent, failure to relieve symptoms including unresolved pain, additional surgery due to loss of fixation, infection or injury, development of spinal conditions, including but not limited to spinal stenosis, spondylolisthesis, or retrolisthesis, removal, revision, reoperation or supplemental fixation of the disc.Patient retained.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: PROTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffery gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16747786
• Report Number: 2031966-2023-00085
• Device Sequence Number: 3428891
• Product Code: MJO
• UDI-Device Identifier: 00843285100009
• UDI-Public: 843285100009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P20022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: SM-4
• Device Lot Number: 4368
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female