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

Model Number	CDM-635L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the lot history record, 129136, for the device did not reveal any non-conformances to specification or deviations in procedure.The device met the m6-c product specifications including the axial stiffness and flexural resistance specifications.The risk management files were reviewed and no new risks were identified.
Event or Problem Description
Information provided states that patient had m6-c implanted at c4/5 and 2 level fusion at c5/6 - c6/7 at unknown time.M6-c was explanted due to facet arthropthy and a fusion was performed.
Additional Manufacturer Narrative
A review of the lot history record, 129136, for the device did not reveal any non-conformances to specification or deviations in procedure.The device met the m6-c product specifications including the axial stiffness and flexural resistance specifications.The risk management files were reviewed and no new risks were identified.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, the device was likely functional at the time of removal, as reported.However, due to the extent of the damage to the fiber construct and with no radiographs, core, or sheath, this could not be confirmed through inspection.
Event or Problem Description
Information provided states that patient had m6-c implanted at c4/5 and 2 level fusion at c5/6 - c6/7 at unknown time.M6-c was explanted due to facet arthropthy and a fusion was performed.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 16436238
• Report Number: 3004987282-2023-00002
• Device Sequence Number: 11544829
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 05/15/2019
• Device Model Number: CDM-635L
• Device Catalogue Number: CDM-635L
• Device Lot Number: 1292136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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 Sex: Male