BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3792317 · Received May 6, 2014

    Report

    Report Number
    1030489-2014-02403
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT T10-ILIUM. IT WAS REPORTED THAT THE DRIVER STRIPPED DURING INSERTION OF THE BONE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272655 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA SV12L0111

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW