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

Model Number 6MM LARGE LONG

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Date 11/03/2021

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 to specification or deviations in procedure.The risk management files were reviewed and no new risks were identified.

Event Description

Patient presented with osteolytic changes.A revision surgery was performed.The device was explanted.The condition of the device at the time of removal is unknown.

Manufacturer Narrative

The radiographic images showed disc replacement at c5/c6 level with a fusion at the c6/c7 level.The fused level has a cage and an anterior fixation system.There is evidence of large osteolytic and cystic lesions along the superior endplate at the disc level.The disc height still maintained; however, there are early degenerative changes at the c4/c5 level.Lack of pre-operative, post-operative and interim images hinders further interpretation.

• 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: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 12849793
• MDR Text Key: 281087086
• Report Number: 3004987282-2021-00057
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 10635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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 Sex: Male
• Patient Weight: 90 KG