BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2922245 · Received January 18, 2013

    Report

    Report Number
    1030489-2013-00164
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 21, 2012
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE UPPER DYNAMIC JAW IS BROKEN OFF AT THE BASE OF THE SHAFT. DURING OPTICAL EXAMINATION DISCOVERED A FAIRLY BRITTLE FRACTURE, WITH PLASTIC DEFORMATION ADJACENT TO THE FRACTURE SURFACE AND MORPHOLOGY SUGGESTING A LATERAL DIRECTION OF FRACTURE. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER TO INDUCE THE FRACTURE OF THE JAW IS CONSISTENT WITH LATERAL BEND STRESS OVERLOAD.

    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 UPPER JAW OF INSTRUMENT WAS BROKEN DURING A POST LUMBAR DISCECTOMY. THE BROKEN TIP WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27271 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11L034

    Patients

    Seq Age Sex Outcome Treatment
    1