BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE STRAIGHT

    MDR report key: 1878086 · Received October 8, 2010

    Report

    Report Number
    3004638600-2010-00005
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE UNIT WAS VISUALLY INSPECTED AND CONFIRMED TO BE BROKEN. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE FOUND THE FRACTURE APPEARANCE TO BE CONSISTENT WITH MECHANICAL OVERLOAD UNDER TORSION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY APPLICABLE NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION SURGERY. DURING SURGERY, WHILE PREPARING THE PEDICLE FOR SCREW INSERTION, THE PROBE BROKE. THE SURGEON ATTEMPTED TO RETRIEVE. THE BROKEN TIP REMAINS IN THE PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE PROBE STRAIGHT PROBE HXB SPINE WAVE, INC. NA 331G08

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR