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

Model Number	6M
Medical Device Problem Codes	Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Osteolysis (2377); Neck Pain (2433); Neck Stiffness (2434); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The build lhr for h80008060 abh009 and h80007539 abe440 was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 36 line 12.75 - device explanted.
Event or Problem Description
Information provided states that a revision surgery was performed to remove two collapsed m6-c discs that were implanted 12/13 years ago.No additional information has been forthcoming.
Additional Manufacturer Narrative
The build lhr for h80008060 abh009 and h80007539 abe440 was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 36 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided radiographic images, the devices showed clear evidence of in vivo mechanical failure after the reported 12-13 years.The devices had collapsed, the sheaths had cleaved, and the endplates at c5/6 were no longer attached to each other and c6-7 endplates were only loosely attached.Furthermore, there was evidence of abrasive contact between the endplates.Without interim radiographs, it was not possible to determine the sequelae of events that led to the failure of this pe.
Event or Problem Description
Information provided states that a revision surgery was performed to remove two collapsed m6-c discs that were implanted 12/13 years ago.No additional information has been forthcoming.Additional information states that the tw m6-c discs were implanted at c5/6 and c6/7.
Additional Manufacturer Narrative
Additional information including radiographic images previously not provided was received in december 2024.The device investigation will be completed again and another supplemental report will be submitted, pending these results.Annex e - 4247 appropriate term/code not available = collapsed disc.
Event or Problem Description
Additional information states five years after initial surgery, pt developed neck pain and neck weakness.A watch-and-see approach was adopted.Follow-up cts over the next four years showed progressive osteolysis, which, in association with worsening cervicalgia, prompted surgical intervention.
Event or Problem Description
Additional information states five years after initial surgery, pt developed neck pain and neck weakness.A watch-and-see approach was adopted.Follow-up cts over the next four years showed progressive osteolysis, which, in association with worsening cervicalgia, prompted surgical intervention.
Additional Manufacturer Narrative
Additional information including radiographic images previously not provided was received in december 2024.Annex e: 4247 appropriate term/code not available, collapsed disc.

• 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: 16850881
• Report Number: 3004987282-2023-00018
• Device Sequence Number: 7555825
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2025

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: 07/31/2018
• Device Model Number: 6M
• Device Catalogue Number: CDM-625
• Device Lot Number: H80008060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023; Not provided; Not provided
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/06/2023; 12/12/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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: 52 YR
• Patient Sex: Female