BEUDAMED
    FDA Adverse Event Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2062380 · Received April 19, 2011

    Report

    Report Number
    1030489-2011-00438
    Date Received
    April 19, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 21, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON A USER FACILITY MEDWATCH THAT THE PATIENT UNDERWENT AN ANTERIOR LUMBER INTERBODY FUSION PROCEDURE AT L4-L5. IT WAS REPORTED THAT DURING THE REMOVAL OF THE PAK NEEDLE FROM L4 DUE TO SCLEROTIC BONE, THE NEEDLE BECAME DIVIDED. IT WAS FOUND THAT A PIECE APPROXIMATELY 1 ¾' LONG REMAINED IN THE L4 PEDICLE. IT WAS DECIDED TO LEAVE THE BROKEN PIECE IN THE BONE SINCE IT WAS INTEROSSEOUS RATHER THAN TRYING TO REMOVE IT WHICH MAY HAVE RESULTED IN POTENTIALLY SIGNIFICANT NEUROLOGIC DAMAGE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION, AMBULATORY AND WAS INSTRUCTED TO FOLLOW-UP WITH THE SURGEON IN 2 WEEKS. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA 0105552W

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Other