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

Model Number	CDM-635L
Medical Device Problem Codes	Collapse (1099); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.(b)(6) in (b)(6) has reached out regarding a m6 patient from 4 years ago with significant osteolysis.
Additional Manufacturer Narrative
Device has been returned for investigation and is pending completion.
Additional Manufacturer Narrative
The device was returned for investigation 9/9/2024.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided radiographic images, the device had failed mechanically at the time of removal.The device was likely not intact, as reported, with in vivo damage visible to the sheath, fiber, and endplates.The core was not returned for inspection and not present between the endplates at the time of removal.Only one pre-revision image was available, which appeared to confirm that osteolysis was present at the time of removal.It was reported that infection was suspected; however, no lab results were provided.Therefore, without further clinical or radiographic information, it is unknown if infection contributed to the removal of this device and the observed osteolysis; however, the device had clearly failed mechanically at the time of removal.The build lhr was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Rmf 0003 rev 39 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.Rmf 0003 rev 39 line 12.42.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical/major intervention, with explantation, involving patient with only a single level m6-c.
Event or Problem Description
It was reported that dr.Ghacham had a patient with signifigant osteolysis.Device was explanted (b)(6) 2024 and returned to manufacturer for analysis.Device was implanted in 2020 at c/5-6 level on a 33 year old female patient.

• 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: 20207018
• Report Number: 3004987282-2024-00028
• Device Sequence Number: 15372663
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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): 10/15/2024

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 Expiration Date: 06/18/2025
• Device Model Number: CDM-635L
• Device Catalogue Number: FG0031-01
• Device Lot Number: 1493247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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: 33 YR
• Patient Sex: Female