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 Date 07/14/2020

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.This is report one (1) of two (2) reports for this event.

Event Description

It was reported that a patient with two m6-c devices was revised.It is unknown if there was a device malfunction or deterioration.Both devices were explanted.

Manufacturer Narrative

A1: (b)(6).B4: (b)(6) 2021.D6b: (b)(6) 2020.D8: no.D9: no.G1: mr.(b)(6).G3: 10-aug-2021.H6: medical device problem code: 2682 - patient - device incompatibility, investigation conclusions: 4315 - cause not established.H10: the condition of the devices at the time of removal is unknown.Limited information was provided; notably, no radiographs, microbiology or pathology reports were provided.It was not possible to assess the potential role of surgical technique based on the provided information.The device was not returned, thus device examination could not be performed.Based on the limited information provided, it is unknown if the device malfunctioned and was not possible to determine the cause of the revision.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 was a two-level implantation.In the us, the m6-c artificial cervical disc is indicated for use following a single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from c3 - c7.The ifu states that the safety and effectiveness of the m6-c artificial cervical disc has not been established in patients with more than one cervical level requiring surgery.

• 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: 10603470
• MDR Text Key: 209131404
• Report Number: 3004987282-2020-00079
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention