BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL)

    MDR report key: 2935491 · Received January 30, 2013

    Report

    Report Number
    2027467-2013-00001
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE REVEALED THE INSTRUMENT WAS PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH DESIGN SPECIFICATIONS. NO IRREGULARITIES WERE IDENTIFIED. BONE PROBES ARE DESIGNED TO LOCATE THE PROPER PATHWAY AND LENGTH OF THE SCREW WHICH IS TO BE IMPLANTED. WHEN USED AS INTENDED THE INSTRUMENT WOULD NOT COME IN CONTACT WITH THE AMOUNT OF FORCE REQUIRED TO FRACTURE AND/OR DEFORM THE TIP IN THIS MANNER.

    Description of Event or Problem · 1

    THE DISTAL TIP OF A XENON CURVED PEDICLE PROBE FRACTURED AND BROKE WHILE REMOVING IT FROM THE PATIENT'S BONE. THE DETACHED SECTION, APPROXIMATELY 1.370 IN LENGTH WAS REMOVED FROM THE PATIENT CAUSING NEARLY SIXTY MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40437 PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 22SPT10 630003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other