BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT BONE PROBE (STAINLESS STEEL)

    MDR report key: 5021629 · Received August 21, 2015

    Report

    Report Number
    2027467-2015-00172
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE INSTRUMENT WAS PROPERLY MANUFACTURED AND RELEASED TO DESIGN SPECIFICATIONS. NO ANOMALIES HAVE BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THAT THE DISTAL TIP OF THE TITANIUM NITRIDE COATED AREA HAD FRACTURED AND SEPARATED FROM THE DEVICE RENDERING IT USELESS. THE BONE PROBE IS 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 DEFORM AND/OR BREAK THE TIP IN THIS MANNER.

    Description of Event or Problem · 1

    THE TIP OF A STRAIGHT PEDICLE PROBE BROKE OFF IN THE PATIENTS PEDICLE. THE EVENT CAUSED THE PATIENT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555159 STRAIGHT BONE PROBE (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 92984 48788R2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other