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

Model Number 7MM LARGE LONG

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional information and the return of the device has been requested.A review of the lot history records for this device did not reveal any non-conformances related to the complaint.

Event Description

It was reported that an m6-c artificial cervical disc was removed due to osteolysis.

Manufacturer Narrative

A1: (b)(6), b4: 07/27/2021, g3: 27-jul-2021, g6: follow-up # 1, h2: additional information.H6 codes: medical device problem code: 2682 - patient-device incompatibility.Type of investigation: 4114 - device not returned.H10: the device was implanted at index level c6/c7 and was in vivo for 46 months in a 42-year-old male patient.In summary, limited information was provided; notably no pre-operative, post-operative, interim, or flexion/extension radiographs were provided.It is not possible to assess the potential role of surgical technique or patient selection based on the provided information.A review of the lot history records for this device did not reveal any relevant non-conformances to device specification.The condition of the device at the time of removal is unknown.Histopathology reports indicated a foreign body reaction to prosthetic debris.Based on the limited information provided, the device did not malfunction.The cause of the pe is undeterminable.

• 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: 10947814
• MDR Text Key: 219865109
• Report Number: 3004987282-2020-00110
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2021
• Device Model Number: 7MM LARGE LONG
• Device Catalogue Number: CDL-737L
• Device Lot Number: 6338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR