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

Model Number	CDL-627
Medical Device Problem Codes	Collapse (1099); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Neck Pain (2433); Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved has not yet been returned for investigation.Risk management files were reviewed and no new risks were identified.Rmf 0003 rev 38 line 12.75 - device explanted.
Event or Problem Description
Device was explanted.No further information is available.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, the device had failed mechanically at the time of removal, at approximately 9 years post-op.The endplates were in contact with evidence of in vivo polishing wear and metal staining visible on the bony ongrowth that remained on the outer surfaces, there was evidence of in vivo impingement and abrasive damage to the sheath, the majority of the fiber construct was not present, and the core was severely deformed with 77% of the initial mass not present; however, without interim radiographs, it was not possible to determine the sequelae of events that contributed to this failure.Further, with no clinical information, histopathology, or microbiology, it is unknown if infection was present and/or contributed to the removal of this device.Rmf 0003 rev 38 line 12.75 - device explanted.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.
Event or Problem Description
Device was returned for investigation.
Additional Manufacturer Narrative
The device was returned for investigation on 10/8/24.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data and images provided, the device had failed mechanically at the time of removal.There was some evidence of collapse; however, the sheath remained present between the endplates, with some fiber visibly protruding, but the core not present between the endplates, nor was it submitted for inspection.Destructive examination of the inner surfaces of the device is needed to examine the integrity of the fiber construct and the condition of the inner surfaces.A pre-revision radiographs were not provided, it is unknown if bony changes had occurred.Therefore, while this device had likely collapsed as reported at the time of removal, the cause was unclear.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 rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was alleged that a m6-c device was collapsed.No revision is planned at this time.Additional information provided reported a patient who received an m6-c in 2018 showed up with severe neck pain.

• 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: avinash thite ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 19032716
• Report Number: 3004987282-2024-00008
• Device Sequence Number: 7019975
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 02/01/2023
• Device Model Number: CDL-627
• Device Catalogue Number: FG005-14
• Device Lot Number: 9441
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024; 07/28/2021
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/10/2024; 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2018
• 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: 37 YR
• Patient Sex: Unknown