BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

    MDR report key: 1082267 · Received July 24, 2008

    Report

    Report Number
    1030489-2008-00371
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 27, 2008
    Manufacturer
    WARSAW ORTHOPAEDIC INC.
    Product Code
    MAX
    PMA / PMN Number
    P000028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE AT C4/5 IMPLANTED AN INTERBODY DEVICE. THE VERTEBRAL BODY HAD BEEN FOUND FRACTURED POST OP. IT REPORTEDLY MIGHT BE DUE TO THE BRITTLE BONE QUALITY. THE SURGEON IS MONITORING THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY ANTERIOR CERVICAL CAGE SYSTEM CAGE MAX WARSAW ORTHOPAEDIC INC. NA W05K3745

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other