BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL)

    MDR report key: 5004016 · Received August 14, 2015

    Report

    Report Number
    2027467-2015-00169
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT HAS NOT BEEN PROVIDED AND IS UNKNOWN. BOTH SECTIONS OF THE FRACTURED INSTRUMENT HAVE BEEN RETURNED FOR EVALUATION. THE PATIENT DID NOT RETAIN A FOREIGN BODY. AN EVALUATION OF THE RETURNED SCIENT'X LENKE CURVED PROBE FOUND THE INSTRUMENT HAD BROKEN APPROXIMATELY 35MM FROM THE DISTAL TIP. THE 35MM LOCATION IS THE TRANSITION POINT WHERE THE 6.35MM DIAMETER SHAFT TAPERS DOWN TO THE POINTED CURVED TIP. THE DISTAL POINTED CURVED TIP CONTAINS THE SMALLEST DIAMETER ON THE INSTRUMENT, AND IS SUBJECT TO THE MOST STRESS DURING USE. 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 TIP OF CURVED PROBE FRACTURED AND BROKE DURING USE. THE EVENT CAUSED NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539251 PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 22SPT10 7088401

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other