BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL)

    MDR report key: 7064727 · Received November 28, 2017

    Report

    Report Number
    2027467-2017-00087
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED LENKE CURVED PROBE FOUND THE INSTRUMENT HAD BROKEN APPROXIMATELY 35 MM FROM THE DISTAL TIP. THE 35 MM LOCATION IS THE TRANSITION POINT WHERE THE 6.35 MM DIAMETER SHAFT TAPERS DOWN TO THE POINTED TIP. THE DISTAL POINTED 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

    BROKEN PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842045 PEDICLE PROBE, LENKE CURVED (STAINLESS STEEL) HXB HXB ALPHATEC SPINE INC 22SPT10 6864602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other