BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDING PROBE

    MDR report key: 4939152 · Received July 24, 2015

    Report

    Report Number
    1526439-2015-10650
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    May 12, 2015
    Report Date
    July 1, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    (B)(4). BALL TIP BROKE OFF WHILE BEING USED IN THE SPINE OF THE PATIENT. ANOTHER INSTRUMENT WAS USED TO FISH OUT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483267 SOUNDING PROBE PROBE HXB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR