BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3233736 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03062
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    August 7, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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: PRODUCT ANALYSIS: THE UPPER JAW IS BROKEN OFF AT THE BASE OF THE DYNAMIC JAW. OPTICAL EXAMINATION DISCOVERED A QUASI-BRITTLE FRACTURE, WITH RIVER LINES AND MORPHOLOGY SUGGESTING THE DIRECTION OF FRACTURE. THE LOCATION, DIRECTION AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE JAW IS CONSISTENT WITH LATERAL BEND STRESS OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH LATERAL BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE JAW OF THE PITUITARY BROKE HOWEVER, NO PARTS ARE MISSING FROM THE INSTRUMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333614 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ10K040

    Patients

    Seq Age Sex Outcome Treatment
    1