BEUDAMED
    FDA Adverse Event Summary report: N

    PROBE

    MDR report key: 4480370 · Received February 3, 2015

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    Report

    Report Number
    1030489-2015-00224
    Date Received
    February 3, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLF AT L5-S1, A MALLET WAS USED TO POUND THE GEARSHIFT INTO SOME HARD BONE AND THE TIP BROKE OFF. THE TIP PORTION WAS LEFT IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78395 PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC NA MK510

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Other