BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 5892790 · Received August 22, 2016

    Report

    Report Number
    1030489-2016-02377
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 28, 2016
    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

    THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOGUE NUMBER 9393009 AND 510K NUMBER K094025 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY DUE TO LEFT LATERAL SIDE HERNIA AT L5/S1. DURING SURGERY, THE SURGEON TAPPED THE CAGE TOO MUCH AND PASSED THROUGH THE OPPOSITE SIDE ANTERIOR LONGITUDINAL LIGAMENT. THE SURGEON RELEASED AN INSERTER FROM THE CAGE. AS A RESULT, THE SURGEON REMOVED THE CAGE USING A NEEDLE-NOSE PLIERS. NEW CAGE WAS REINSERTED IN THE PATIENT BECAUSE THE CAGE WAS BROKEN ALTHOUGH IT WAS REMOVED FROM THE PATIENT'S BODY. THE PRODUCT CAME IN CONTACT WITH PATIENT. NO FRAGMENTS OF THE PRODUCT REMAINED IN THE PATIENT. ANTERIOR LIGAMENT OF THE PATIENT WAS PERFORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544596 CRESCENT SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MSD DEGGENDORF MFG NA 48BW

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other