BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2072638 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00465
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFERIOR MICROPITUITARY SHAFT TIP IS BROKEN OFF AT THE CENTER OF THE JAW PIVOT PIN FORWARD. THE BROKEN OFF PORTION OF THE SHAFT AND PIVOT PIN ARE MISSING AND NOT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION REVEALS A FAIRLY BRITTLE FRACTURE SURFACE, WITH NO INDICATION OF FATIGUE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCES TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM JAW BROKE OFF COMPLETELY AS THE SURGEON WAS PULLING TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK NA GZ10C044

    Patients

    Seq Age Sex Outcome Treatment
    1