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

Model Number MD-5

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial two (2) level cervical total disc replacement on an unknown date.Subsequently, the patient underwent a revision surgery to remove one disc prosthesis.The reason for removal or the scope of the revision procedure was not provided.No further patient impact was reported.No additional information is available.

Manufacturer Narrative

The explanted device was returned directly to a third-party lab for evaluation and their investigation is currently in process.Once the investigation has been completed, a supplemental report will be submitted.Radiograph images were provided and the review identified the patient had two-level ctdr at the c4/5 and c5/6 (approximate) levels with an anterior cervical discectomy and fusion (acdf) interbody with interfixation at the superior adjacent-level, c3/4 (approximate) level.Evidence of successful interbody fusion at the c3/4 level was observed.Both ctdr devices were noted to be in good position within the disc spaces within the lateral radiograph; further, the c5/6 disc appeared to be in good position in the ap radiograph however, the position of the c4/5 disc appeared to be slightly to the right of midline.There did not appear to be significant radiolucencies or evidence of device migration or subsidence.The anterior prevertebral soft tissue shadow was noted to be widened along the c3-c7 levels and significant calcification of both vertebral arteries was observed.A definitive reason for removal of one of the disc prosthesis was not apparent from review of the images provided.Information regarding the timing of the event, the patient's post-operative activity levels, and/or if the patient experienced any trauma was not provided.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.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." ".Preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all comorbidities, 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 osteopenic.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." ".Cervical artificial disc risks: risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: removal, revision, reoperation or supplemental fixation of the disc." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: lot number for the implant involved is either w81136 or w83746; expiration date: 02/02/2026 or 07/08/2026.H4: manufacturing date: 03/03/2022 or 08/23/2022.A review of the device history record was performed and no discrepancies relevant to the reported event were found.Review of the sterilization certificate identified that the product was sterilized according to the sterilization specifications.

Event Description

It was reported that the patient underwent an initial two (2) level cervical total disc replacement (ctdr) at c5/6 and c6/7 with an anterior cervical discectomy and fusion (acdf) at c4/5 to treat foraminal stenosis and disc protrusion from c5-7.Subsequently, approximately 16 months later, the patient underwent a revision procedure to remove the c5/6 disc prosthesis due to subsidence at the c6 superior endplate, resulting in a loss of height and recurring radiculopathy.The revision was completed by placement of a fusion interbody at the c5/6 disc space.No further patient impact was reported.No additional information is available.

• Brand Name: NUVASIVE SIMPLIFY CERVICAL ARTIFICIAL DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18960667
• MDR Text Key: 338376800
• Report Number: 2031966-2024-00084
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843285100061
• UDI-Public: 843285100061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MD-5
• Device Catalogue Number: N/A
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female