BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER

    MDR report key: 3821295 · Received May 20, 2014

    Report

    Report Number
    1030489-2014-02581
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    July 25, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION OF THE FRACTURE SUGGESTS BEND STRESS OVERLOAD AT THE TIP WELD JOINT AS THE MECHANISM OF FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). THE INSTRUMENT WAS BEING USED TO DISTRACT THE PATIENT'S DISC SPACE IN PREPARATION FOR A GRAFT TO BE INSERTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300029 IMPLANT INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA MA04C022

    Patients

    Seq Age Sex Outcome Treatment
    1