BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3061879 · Received April 16, 2013

    Report

    Report Number
    1030489-2013-01072
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    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

    (B)(6). (B)(4). THE INSTRUMENT 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 SCREW THAT HOLDS BOTH "LIPS" OF THE JAW TOGETHER FELL OFF DURING AN UNKNOWN SPINE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163938 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GZ07D117

    Patients

    Seq Age Sex Outcome Treatment
    1