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

Model Number	CDM-625
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the lot history record, h80002145, 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 the patient experienced pain and lysis zone could be seen in the bone 13 years post implant of an m6-c prosthesis.The patient had been diagnosed with multiple sclerosis at the time of initial implant in 2010.The m6-c was explanted.
Event or Problem Description
Information provided states the patient experienced pain and lysis zone could be seen in the bone 13 years post implant of an m6-c prosthesis.The patient had been diagnosed with multiple sclerosis at the time of initial implant in 2010.The m6-c was explanted.
Additional Manufacturer Narrative
A review of the lot history record, h80002145, 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 and images provided, this device had failed mechanically at the time of removal.The device had collapsed and in vivo damage was noted to the sheath, fiber construct, and core.Large cystic bony changes were observed on the pre-revision imaging, were consistent with the reported osteolysis, histopathology, wear of the fiber construct, and the fiber filaments visible on the outer surfaces of the endplates.With no interim radiographs were provided, the sequelae of events that led to the failure of this procedure is unknown.

• Brand Name: M6-C
• Common Device Name: ARTIVICAL 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: 16432435
• Report Number: 3004987282-2023-00001
• Device Sequence Number: 20186374
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 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: 08/30/2014
• Device Model Number: CDM-625
• Device Catalogue Number: CDM-625 (FG 0005-01)
• Device Lot Number: H80002145
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2009
• 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: 57 YR
• Patient Sex: Female