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

Model Number	6L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states patient developed radicular pain three (3) weeks post implant with display of spondylolisthesis at c3-c4 operative level.Pt had previous acdf c5-c6 signs of auto fusion at c4-c5 level.
Additional Manufacturer Narrative
It was reported that the patient developed radicular pain 3 weeks post operation displaying spondylolisthesis.The device was explanted.The condition of the device at the time of removal was unknown.Multiple attempts were made to gather additional information from the site up to including the device return without success.Radiographic imaging was provided and reviewed.The lateral view shows disc replacement and fusion showing degenerative changes at c4/5 and large anterior osteophyte.Oblique view shows fusion and disc replacement and degenerative disc between the two.Cervical lordosis and slight translation of superior endplate at c3/4.Nothing to suggest loosening or any other changes.Cervical lordosis is not visible in last image.A review of the lot history records for this device revealed there were no relevant ncmrs associated with the lot.The device was not returned; therefore, no device examination could be performed.No microbiology or pathology laboratory testing reports and/or results were provided.Based on the limited information, it was not possible to determine the cause of the product experience.

• Brand Name: ARTIFICIAL CERVICAL DISC
• Common Device Name: M6-C
• Manufacturer (Section D): SPINAL KINETICS LLC; 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: 15070978
• Report Number: 3004987282-2022-00053
• Device Sequence Number: 20193521
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2022

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-627
• Device Lot Number: 1694679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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: Male