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

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device did not return for investigation.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain rmf 0003 rev 38 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 line 12.75 - device explanted.
Event or Problem Description
It was reported the patient developed severe osteolysis.First attempt to revise and relive pressure on the cord was done by laminoplasty at c3/4/6 level earlier this year.Date tba.Doctor made the decision to remove the failed disc and fuse c4/6 level.C5/6 level still intact so it was not revised.Patient developed pain and weakness and a ct revealed a failed m6-c device and osteolysis at c3/4.It was revised and fused with a cage and plate.
Additional Manufacturer Narrative
It was reported that the patient developed pain and weakness, and imaging revealed failed m6-c device and osteolysis.The doctor removed the failed disc and fused c4/5 level.The c5/6 level m6-c was still intact and not revised.Radiographic images were not provided for review.Microbiology/pathology reports and results were also not provided.The device was not returned and therefore examination of the explant could not be completed.With the information provided, it is not possible to determine the cause of the reported failure for this product experience.Should additional information be provided, the pe will be amended.A serial number was reported by the rep.However, the provided serial number does not exist in the m6 database.Currently, the serial number build is on agdxxx.Attempts were made to verify the serial number for the device in this incident without success.Without a valid serial number, a review of the lhr cannot be completed.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 38 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 line 12.75 - device explanted.
Event or Problem Description
It was reported the patient developed severe osteolysis.First attempt to revise and relive pressure on the cord was done by laminoplasty at c3/4/6 level earlier this year.Date tba.Doctor made the decision to remove the failed disc and fuse c4/6 level.C5/6 level still intact so it was not revised.Patient developed pain and weakness and a ct revealed a failed m6-c device and osteolysis at c3/4.It was revised and fused with a cage and plate.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: james stephens ; 501 mercury dr.; sunnyvale, CA 94085
• MDR Report Key: 19513637
• Report Number: 3004987282-2024-00022
• Device Sequence Number: 4035969
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: CDL-637L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male