BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE

    MDR report key: 4890445 · Received July 6, 2015

    Report

    Report Number
    1030489-2015-01356
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 15, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:APPROXIMATELY ~38MM OF TIP HAS BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS. FRACTURE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. DIMENSIONAL AND MATERIAL HARDNESS INSPECTED AND FOUND TO BE CONFORMING TO PRINT SPECIFICATION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, INTRA-OP, AFTER PLACING THE THORACIC PROBE IN THE PEDICLE, THE SURGEON HAD TROUBLE REMOVING IT. IT WAS STUCK. IN HIS ATTEMPT TO REMOVE IT, IT SNAPPED OFF. SEVERAL DIFFERENT WAYS OF REMOVING BROKEN PIECE WERE ATTEMPTED BEFORE THE SURGEON DECIDED TO BUR AROUND THE BROKEN PIECE UNTIL HE COULD APPLY LOCKING PLIERS TO THE END OF IT. AT THAT TIME THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECE. NO FRAGMENTS OF THE BROKEN PROBE REMAINED INSIDE THE PATIENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434434 PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC NA SW11C623

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other