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

Model Number	6L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant removed easily, no pus evident, polyethylene fibers had disintegrated.Accounted for sheath and two end plates, but no core was found.Surgeon sent multiple samples for histology and mcs.
Event or Problem Description
Information provided states that patient had neck and radicular arm pain.Surgeon removed m6-c implant and replaced with acdf.
Additional Manufacturer Narrative
The provided information indicated that the device was not intact at the time of revision.Inspection of the sheath showed cleaving with jagged and crushed edges, abrasive damage, and missing material.The device was appropriately sized and placed.Evidence of bony changes were present as well as an osteolytic cyst.Subsequent lateral images showed that the endplates had translated with respect to each other and that the disc replacement was unstable and had lost height.The explant lab notes that a fusion was present directly superior to the level of the disc replacement, prior to the implantation of the disc replacement.The device showed clear evidence of in vivo mechanical failure.The device had collapsed, the sheath had cleaved, the endplates were no longer attached to each other, the bulk of the fiber construct and the core were not found during surgery.Furthermore, there was evidence of abrasive contact between the endplates.The build lhr for ln 4039 sn (b)(6) was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with the lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.

• 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 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 15089427
• Report Number: 3004987282-2022-00054
• Device Sequence Number: 14482974
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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 Model Number: 6L
• Device Catalogue Number: CDL-737L
• Device Lot Number: 4039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2015
• 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: 44 YR
• Patient Sex: Male