BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2850737 · Received November 29, 2012

    Report

    Report Number
    1030489-2012-02474
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TOTAL OF 19 PATIENTS (B)(6) UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT OSTEOPOROTIC COMPRESSION FRACTURES DUE TO PRIMARY OSTEOPOROSIS. ALL PATIENTS REPORTEDLY HAD PAIN THAT COULD NOT BE REDUCED BY 8 WEEKS OR MORE OF CONSERVATIVE TREATMENT. GENERAL ANESTHESIA WAS USED IN ALL CASES. OPERATING TIME AVERAGED 27 MINUTES (19 TO 39 MIN) AND NO INTRA-OPERATIVE COMPLICATIONS WERE OBSERVED. IT WAS REPORTED THAT CEMENT LEAKED FROM THE ENDPLATE INTO THE INTERVERTEBRAL DISC IN FIVE (5) PATIENTS. THE CEMENT WAS REPORTEDLY IN A DOUGHY AND HOMOGENOUS STATE PRIOR TO DELIVERY INTO EACH PATIENT AND THE INSTRUCTIONS FOR USE (IFU) WAS FOLLOWED DURING EACH PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR BKP