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

Model Number 6MM LARGE

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

Patient Problems Unspecified Infection (1930); Osteolysis (2377)

Event Date 12/14/2021

Event Type  Injury  

Event Description

Two level patient revised due to infection.Both devices were explanted.Both devices were not intact at the time of removal.

Manufacturer Narrative

Additional information 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.This is one (1) of two (2) reports submitted on this event.

Manufacturer Narrative

The radiographic images revealed a kyphotic posture of the cervical spine with degenerative changes at c5/c6 level.There was a disc replacement at c5/c6 level where it appeared to be appropriately placed and sized.There was a radiolucency at the superior disc replacement endplate and the c5 vertebral body with the appearance of osteolytic lesions at the posterior corner.

Manufacturer Narrative

Additional radiographs were received and reviewed.The c6/c7 disc replacement is in slight kyphosis and there is no evidence of loosening.There is no evidence of involvement of the spinal canal.

• 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: 13232141
• MDR Text Key: 285239014
• Report Number: 3004987282-2021-00063
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2024
• Device Model Number: 6MM LARGE
• Device Catalogue Number: CDL-627
• Device Lot Number: 1292137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female