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

Model Number	7LL
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that patient had an m6-c device implanted at c6/7 and an anterior cervical discectomy and fusion (acdf) at c7/t1.The patient began experiencing pain and discomfort.Radiographic imaging showed the m6-c disc had collapsed.A revision surgery was performed to remove the disc.
Additional Manufacturer Narrative
The build lhr for fg 0031-15 h80007988 (b)(4) was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were reviewed and no new risks have been identified.Rmf 0003 rev 36 line 15 - failure to relieve symptoms including unresolved pain.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 patient had an m6-c device implanted at c6/7 and an anterior cervical discectomy and fusion (acdf) at c7/t1.The patient began experiencing pain and discomfort.Radiographic imaging showed the m6-c disc had collapsed.A revision surgery was performed to remove the disc.
Additional Manufacturer Narrative
The build lhr for fg 0031-15 h80007988 (b)(6) was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk management files were reviewed and no new risks have been identified.Rmf 0003 rev 36 line 15 - failure to relieve symptoms including unresolved pain 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 device showed clear evidence of in vivo mechanical failure at approximately 9 years post-op.The device had collapsed, the sheath had cleaved, the endplates were no longer attached to each other, the fiber construct and the core were not present.Furthermore, there was evidence of abrasive contact between the endplates.Pre-revision images confirmed the presence of the reported lytic changes (osteolysis), also confirmed through histology.Without interim radiographs, it was not possible to determine the sequelae of events that led to the failure of this pe.

• 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 LLC; 501 mercury drive; sunnyvale CA
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 16690546
• Report Number: 3004987282-2023-00009
• Device Sequence Number: 20361498
• Product Code: MJO
• UDI-Device Identifier: 00812388030087
• UDI-Public: 00812388030087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 06/30/2019
• Device Model Number: 7LL
• Device Catalogue Number: CDL-737L
• Device Lot Number: H80007988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2013
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 85 KG