BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3232719 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03059
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    September 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. OPTICAL EXAMINATION DISCOVERED A QUASI-BRITTLE FRACTURE, WITH WITNESS MARKS AND A FRACTURE MORPHOLOGY SUGGESTING A LATERAL 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TOP PIECE OF THE PITUITARY BROKE OFF DURING SURGERY AND WAS RECOVERED BY THE SURGEON. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334722 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11D021

    Patients

    Seq Age Sex Outcome Treatment
    1