BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3677721 · Received March 13, 2014

    Report

    Report Number
    1030489-2014-01833
    Event Type
    Injury
    Date Received
    March 13, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) AT AN UNKNOWN LEVEL. IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST-OP, THE BKP TREATED VERTEBRA WAS "COLLAPSED". A REVISION PLF SURGERY WAS PERFORMED AT LEVELS T9-L3 TO TREAT THE PATIENT'S KYPHOSIS. CEMENT WAS NOT REMOVED FROM THE BKP-TREATED LEVEL DURING THE REVISION. THE PATIENT IS REPORTEDLY RECOVERING FROM THE PROCEDURE WELL AND NO POST-PLF COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150361 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention