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

Model Number 6MM MEDIUM LONG

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure.Additional information and the return of the device has been requested.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.This is one (1) of two (2) reports submitted on this event.

Event Description

It was reported that a two-level patient was revised.Both devices were explanted.

Manufacturer Narrative

G1: mr.(b)(6).Manufacturer narrative: two m6-cs were removed but there was no stated reason for the explantation.The radiographs showed two m6-cs implanted at c4/c5 and c5/c6 with loss of height above a fusion at c6/c7.It was noted that sonication of implant revealed staphylococcus cohnii.The devices were not returned thus device examination could not be performed.Limited information was provided; notably, no pre-operative or flexion/extension radiographs were provided.It was not possible to assess the potential role of surgical technique based on the provided information.A review of the lot history records for this device did not reveal any relevant non-conformances to specification or deviations in procedure.While there was an infection present, based on the limited information provided, it was not possible to ascertain the relationship between these factors and the explanation.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: 9589416
• MDR Text Key: 175074723
• Report Number: 3004987282-2020-00003
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 6MM MEDIUM LONG
• Device Catalogue Number: CDM-635L
• Device Lot Number: H80008205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR