BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3850656 · Received June 5, 2014

    Report

    Report Number
    1030489-2014-02710
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TIP OF THE T25 OBTURATOR HAS BEEN SHEARED OFF AND IS MISSING: CAUSE UNKNOWN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT ENGAGE THE SCREW DUE TO EXCESSIVE USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330019 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA PR11J034

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW