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

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The condition of the device upon removal was unknown.The device was not returned, thus device examination could not be performed.Additional information and the return of the device has been requested.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 radiographic images showed the c5/c6 disc replacement has shifted with its inferior endplate moving anteriorly.There was evidence of radiolucency with osteolysis and cystic lesions surrounding both implants.Limited information was provided, notably no pre-operative, post-operative, interim or flexion/extension radiographs were provided.While evidence of infection and osteolysis were present, it was not possible to determine the sequelae or the cause of the event.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 report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.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 removed.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: peter kollings ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 11861370
• MDR Text Key: 251904752
• Report Number: 3004987282-2020-00106
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention