BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2771682 · Received October 4, 2012

    Report

    Report Number
    1030489-2012-01813
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 5, 2012
    Report Date
    February 25, 2014
    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

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FUNCTIONALLY EVALUATED THE BED RAIL ATTACHMENT END OF THE INSTRUMENT BY ATTEMPTING TO MANUALLY MOVE, REMOVE OR MANIPULATE THE INSTRUMENTS AT THE ATTACHMENT POINTS AFTER TIGHTENING. UNABLE TO MANUALLY MOVE, REMOVE OR MANIPULATE MANUALLY AFTER TIGHTENING. AFTER VISUAL AND FUNCTIONAL EVALUATION THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE FLEX ARM WILL NOT STAY ATTACHED TO THE BED RAIL ATTACHMENT MAKING IT UNABLE TO BE USED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC MY12E002

    Patients

    Seq Age Sex Outcome Treatment
    1