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

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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 a single-level patient was revised.The m6-c artificial cervical disc was removed.

Manufacturer Narrative

A1: (b)(6).B4: (b)(6) 2021.G3: 12-aug-2021.H6: medical device problem code: 2682 - patient - device incompatibility.H10: limited information was provided; notably, no pre-operative, post-operative, interim, or flexion/extension radiographs were provided.It was not possible to assess the potential role of surgical technique or patient selection based on the provided information.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 device was not returned, thus device examination could not be performed.No microbiology or pathology reports were provided.Based on the paucity of information provided, the device did not malfunction and it was not possible to determine the cause of the complaint.The risk management files were reviewed and no new risks were identified in the available reported information for this event 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.

• 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: 11686506
• MDR Text Key: 246648800
• Report Number: 3004987282-2020-00089
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention