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

Model Number 2-5-CE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Stenosis (2263); Intervertebral Disc Compression or Protrusion (4524); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of manufacturing records was performed and no discrepancies relevant to the reported event were found.Information regarding the reason the patient was scheduled to receive diagnostic imaging or the plan to explant the prosthesis was requested but was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Warnings: 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: 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." 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 one-level cervical total disc replacement procedure at c5/6 as a part of a clinical study.Subsequently, a ct scan has been scheduled approximately seven (7) years later and the surgeon is planning to remove the total disc prosthesis.The reason for the scheduled diagnostic imaging and intent to remove the implant has been requested from the site but was not available.No additional information is available.

Manufacturer Narrative

The explanted device was sent to a third-party lab for analysis.Upon completion of the investigation or if any additional, relevant information becomes available, a supplemental report will be filed.

Event Description

It was reported that the patient underwent an initial one-level cervical total disc replacement procedure using the simplify disc at c5/6 as a part of a clinical study and to address left c5/6 disc herniation.Approximately seven (7) years later, a revision surgery was performed where the simplify disc was removed and a three-level fusion procedure was performed from c4 to c7.The surgeon cited the breakdown of the cervical levels superior and inferior to the simplify disc as the reason for the removal of the disc and the move to a fusion procedure.The revision procedure was reportedly successful with no problems encountered and there were no noted issues with the simplify disc itself.No additional information is available.

Event Description

It was reported that the patient underwent an initial one-level cervical total disc replacement procedure using the simplify disc at c5/6 as a part of a clinical study and to address left c5/6 disc herniation.Approximately seven (7) years later, a revision surgery was performed where the simplify disc was removed and a three-level fusion procedure was performed from c4 to c7.The surgeon cited the breakdown of the cervical levels superior and inferior to the simplify disc as the reason for the removal of the disc and the move to a fusion procedure; specifically, to address severe neck and arm pain, decreased upper extremity reflexes and sensation, severe stenosis, cervical myelopathy, and loss of disc space height at c4/5, and a collapsing disc at c6/7 with foraminal stenosis at severe left c6/7.The revision procedure was reportedly successful with no problems encountered and there were no noted issues with the simplify disc itself.No additional information is available.

Manufacturer Narrative

Additional information: a5, b5, b7, d9, h6, h10.Per index procedure operative notes, the surgeon was not completely satisfied with the positioning of the implanted simplify disc due to the concavity of the c5 vertebral body being slightly posterior, causing the core of the implant to not sit quite in the center of the implant plates; however, the positioning was determined to be adequate as the posterior aspect of the simplify disc was even with the posterior of the vertebral body, as seen by x-ray and using the depth gauge instrument.

• 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: 17205897
• MDR Text Key: 317909764
• Report Number: 2031966-2023-00134
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843285101976
• UDI-Public: 843285101976
• 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,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: 2-5-CE
• Device Catalogue Number: N/A
• Device Lot Number: 2874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 07/26/2023
• Supplement Dates FDA Received: 08/09/2023; 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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): Other; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White