BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR RAMP INSTRUMENT

    MDR report key: 999133 · Received February 19, 2008

    Report

    Report Number
    2246640-2008-00002
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL IS IN POSSESSION OF DEVICE. SALES AGENCY REPRESENTATIVE IS ATTEMPTING TO OBTAIN PHOTOS OF THE DEVICE OR HAVE IT RELEASED AND RETURNED FOR EVALUATION. EVALUATION METHOD THEREFORE WAS LIMITED TO EVALUATION OF INVENTORY ITEMS AND REVIEW OF PRODUCT COMPLAINT AND REPAIR HISTORY. NO SIMILAR INCIDENTS ARE ON RECORD. INCIDENT APPEARS TO BE DUE TO NORMAL WEAR AND TEAR. INSTRUMENT IS OVER 4 YEARS OLD, HAS NOT BEEN SERVICED OR INSPECTED SINCE ORIGINAL SHIPMENT IN 2003. SALES AGENCY REPRESENTATIVE HAS BEEN FORWARDED FDA PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS. REPORT TO BE UPDATED WHEN DEVICE EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    SALES AGENCY REPRESENTATIVE REPORTED THAT DURING OR POST-SURGERY, IT WAS NOTICED THE PIN IN THE INSTRUMENT HINGE HAD FALLEN OUT AND WAS MISSING. OR PERSONNEL WERE UNSURE WHERE IT WENT. PATIENT WAS X-RAYED, BUT IT DID NOT SHOW UP. PIN IS STAINLESS STEEL AND APPROX. 1 MM X 5 MM IN SIZE; SHOULD BE READILY OBSERVABLE ON X-RAY. INSTRUMENT HAS BEEN RETAINED BY HOSPITAL, REP IS ATTEMPTING TO GET PICTURES AND RETURN INSTRUMENT AS SOON AS POSSIBLE. NO PATIENT INJURY WAS NOTED, SURGICAL OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTERIOR RAMP INSTRUMENT ORTHOPEDIC SURGICAL INSTRUMENT LXH OSTEOTECH, INC. 126 FD132148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other GRAFTECH ANTERIOR RAMP BONE GRAFT