BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3183383 · Received June 22, 2013

    Report

    Report Number
    1030489-2013-02448
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY AT T10 AND DURING THE PROCEDURE ONE OF THE BALLOONS RUPTURED. ACCORDING TO THE REPORT, NO FRAGMENTS REMAINED IN THE PATIENT AND THE PATIENT DID NOT HAVE AN ALLERGIC REACTION. PATIENT REPORTEDLY HAS "HARD SCLEROTIC BONE" AND THE PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284023 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR