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

Catalog Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive qa for evaluation; further, no operative notes and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was unable to be performed as the part and 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." ".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." ".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.

Event Description

It was reported that the patient underwent an initial cervical total disc replacement at an unknown level(s) on an unknown date.Subsequently, the patient underwent a revision surgery to remove the 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.

• 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: 19000786
• MDR Text Key: 338881759
• Report Number: 2031966-2024-00087
• Device Sequence Number: 1
• Product Code: MJO
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• 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 Sex: Prefer Not To Disclose