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

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Revision surgery occurred (b)(6) 2014.Exact date of revision surgery was not provided.Without a lot number, the device history records review could not be completed.Additional information and the return of the device has been requested.

Event Description

It was reported that an m6-c was explanted.It is unknown if the device malfunctioned.

Manufacturer Narrative

(b)(6).Medical device problem code: 2682 - patient - device incompatibility.Investigation conclusions: 4315 - cause not established.H10: radiographic images were not provided.No microbiology or pathology results were provided.The device was not returned, thus device examination could not be performed.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.Limited information was provided; notably, no pre-operative, and post-operative, interim, or flexion/extension radiographs were provided.Without such information it is not possible to assess the potential role of patient conditions, m6-c placement, and surgical technique.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.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale, ca
• MDR Report Key: 10446347
• MDR Text Key: 204171797
• Report Number: 3004987282-2020-00075
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR