MAUDE Adverse Event Report: SPINAL KINETICS LLC M6-C; ARTIFICIAL CERVICAL DISC

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Additional information and the return of the device has been requested.Without a lot number, the device history records review could not be completed.

Event Description

An m6-c was revised.The device was implanted at index level c5/6 and was in vivo for 90 months.This device was a one-level implantation.The device was explanted.The condition of the device at the time of removal is unknown.

Manufacturer Narrative

A1: pe 20-127 b4: (b)(6) 2021.G3: (b)(6) 2021.G6: follow-up #1 h2: additional information h6: medical device problem code: 2682 - patient-device incompatibility.H10: it was reported that osteolysis was detected and the device was explanted.Limited information was provided; notably, the device was not returned, no radiographs, and no lab reports were provided.It was not possible to assess the potential role of surgical technique or patient selection based on the paucity of information provided.No device, serial or lot number has been provided, therefore, a review of the lot history records for this device could not be performed.The risk management files were reviewed and no new risks were identified in the available reported information for this pe that require any changes to the current fmea, risk analysis, or labeling.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.As such, we are reporting this incident to err on the side of caution.Spinal kinetics' post-market surveillance procedures require multiple attempts to gain as much detailed information as possible regarding the reported event.No further investigation can be performed.Based on the limited information provided, the device did not malfunction and it was not possible to determine the cause of the complaint.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• MDR Report Key: 10972728
• MDR Text Key: 220632391
• Report Number: 3004987282-2020-00102
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1