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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Additional information, including the serial number has been requested.Without a device, serial number or lot number, the device history records review could not be completed.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.

Event Description

It was reported that and m6-c patient presented with fever one (1) week post op.Revision surgery performed, cultures taken, the device remains implanted.

Manufacturer Narrative

A1: pe 21-56.B4: 24-aug-2021.G3: 24-aug-2021.G6: follow-up #1.H2: additional information.H10: 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: 12243018
• MDR Text Key: 264067823
• Report Number: 3004987282-2021-00025
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention