BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3241335 · Received July 22, 2013

    Report

    Report Number
    1030489-2013-03077
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DURING A BALLOON KYPHOPLASTY PROCEDURE, ONE OF THE BALLOON(S) RUPTURED IN THE PATIENT. REPORTEDLY, THE SURGICAL TIME WAS EXTENDED FOR LESS THAN 30MINS DUE TO THE INCIDENT. NO PATIENT ALLERGIES TO THE CONSTRAST MEDIA WERE REPORTED AND NO FRAGMENTS OF THE BALLOON WERE LEFT BEHIND. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340040 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP