BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1820048 · Received August 20, 2010

    Report

    Report Number
    1030489-2010-01079
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS RETURNED FOR EVALUATION. THE ANGLE AND LOCATION OF TIP BREAKAGE SUGGEST THE ROD WAS NOT FULLY ENGAGED INTO THE MOUTH OF THE INSTRUMENT, POTENTIALLY RESULTING IN OVERLOAD OF THE OUTSIDE CORNERS OF THE INSTRUMENT, AND CONTRIBUTING TO THE FOREGOING DEFORMATION AND BREAKAGE. MICROSCOPIC EXAMINATION IS NOT POSSIBLE DUE TO FRACTURE SURFACE DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGERY FROM T2-SACRUM. DURING THE SURGERY, THE TIP OF THE ROD BENDER BROKE WHILE BEING USED TO PERFORM LATERAL BENDING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ROD BENDER LXH MEDTRONIC SOFAMOR DANEK NA NM07A009

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR EXPLANT:| IMPLANT:| ROD