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

Model Number CDM-625

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/24/2023

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 310129582
• Report Number: 3004987282-2023-00001
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female