BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5375840 · Received January 19, 2016

    Report

    Report Number
    1030489-2016-00190
    Event Type
    Injury
    Date Received
    January 19, 2016
    Report Date
    December 22, 2015
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG NUMBER: 9393009 AND 510K NUMBER: K094025 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT UNSPECIFIED SPINAL PROCEDURE WITH IMPLANTATION OF CAGE AND SCREW. ON AN UNKNOWN DATE POST-OP, THE CAGE WAS FOUND TO BE "MOVING". REVISION WAS PERFORMED ON ANOTHER FACILITY TO REPLACE THE CAGE.FUSION DID NOT OCCUR. SURGEON'S COMMENTED THAT THE CAUSE OF MIGRATION OF CAGE IS UNKNOWN BECAUSE INITIAL WAS CONDUCTED BY OTHER HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35306 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention