BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2911184 · Received January 11, 2013

    Report

    Report Number
    1030489-2013-00120
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SINGLE LEVEL BALLOON KYPHOPLASTY WAS PERFORMED ON A PATIENT. DURING THE PROCEDURE, ONE OF THE BALLOONS "JAMMED WHEN INTRODUCING IT INTO THE VERTEBRAL BODY THROUGH THE CANNULA". A NEW BALLOON WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17649 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULA