BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 2954953 · Received February 11, 2013

    Report

    Report Number
    1030489-2013-00440
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    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 PATIENT UNDERWENT A LAMINECTOMY. IT WAS REPORTED THAT DURING THE PROCEDURE THE JAW OF THE UPBITING PITUITARY BROKE OFF. THE PIECES WERE RECOVERED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58620 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ11E027

    Patients

    Seq Age Sex Outcome Treatment
    1