BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2771658 · Received October 4, 2012

    Report

    Report Number
    1030489-2012-01812
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFERIOR STATIC JAW IS BENT AND BROKEN AT THE CENTERLINE OF THE PIVOT PIN HOLE, AND THE PIVOT PIN IS MISSING AND NOT RETURNED FOR ANALYSIS. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER TO BEND AND INDUCE FRACTURE OF THE JAW, IS CONSISTENT BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. IT WAS REPORTED THAT THE HANDLE SCREW IS MISSING FROM THE PITUITARY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC GZ10J090

    Patients

    Seq Age Sex Outcome Treatment
    1