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

Model Number 6MM MEDIUM LONG

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 10/19/2020

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.Two level patient revised.Both devices were explanted.The devices appear to have been revised for infection.The devices showed no evidence of mechanical failure.No radiographs or lab reports were provided.The devices had not collapsed, there was no evidence that the inner endplates had been in contact, and the sheath, fiber, and core showed no or minimal in vivo damage.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.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 originally reported that an m6-c is scheduled to be revised.No device malfunction or deterioration alleged.New information was later reported that two m6-c devices were explanted.The devices appear to have been revised for infection.The condition of the device at the time of removal is unknown.

• 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: 12379054
• MDR Text Key: 268521716
• Report Number: 3004987282-2021-00031
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

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: 09/27/2022
• Device Model Number: 6MM MEDIUM LONG
• Device Catalogue Number: CDM-635L
• Device Lot Number: 8744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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