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

Model Number 6MM LARGE

Device Problems Collapse (1099); Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Both devices were implanted in (b)(6) 2010, the exact implantation date was not provided.Additional information and the return of the device have been requested.A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure.The risk management files were identified in the available reported information for this pe that require any changes to the current fmea, risk analysis, or labeling.This was a two-level implantation.This is one (1) of two (2) reports submitted on this event.

Event Description

It was reported that a two-level patient was revised due to implant failure after cervical disc prosthesis implantation at levels c5/6 and c6/7.Segmental collapse/implant loosening with osteolysis was reported.Further, cervical vertebrae reportedly had to be removed at revision operation.Both devices were explanted.The condition of the devices 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: 12587175
• MDR Text Key: 275213085
• Report Number: 3004987282-2021-00052
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2011
• Device Model Number: 6MM LARGE
• Device Catalogue Number: CDL-627
• Device Lot Number: H80001670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2009
• 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
• Patient Age: 59 YR