BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLT PROBE

    MDR report key: 4867259 · Received June 25, 2015

    Report

    Report Number
    1030489-2015-01292
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 2, 2015
    Manufacturer
    SOFAMOR DANEK
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K) : I REFERRED DIFFERENT PROBES STRAIGHT ( 836-037 ) , CURVED ( 836-036 ) AND FLAT ( 803-290) AND FOUND ALL OF THEM TO BE EXEMPT. NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES RECEIVED . HENCE, NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PRODUCT BROKE INTO TWO PIECES AND THE TIP OF IT BROKE OFF IN THE VERTEBRAE AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413410 HOLT PROBE PROBE HXB SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other