BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2925703 · Received January 22, 2013

    Report

    Report Number
    1030489-2013-00199
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 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)(6). (B)(4). LOCATION : HOSPITAL. 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 PROCEDURE TO TREAT AN OSTEOPOROTIC COMPRESSION FRACTURE AT T12. DURING SURGERY, IT WAS REPORTED THAT CEMENT MIGRATED FROM THE CAUDAL ENDPLATE BUT THE PATIENT WAS ASYMPTOMATIC SO ADDITIONAL INTERVENTION WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THE CEMENT WAS NOT STORED AT 23 +/-1°C FOR 24 HOURS PRIOR TO USE BUT IT WAS "DOUGHY AND HOMOGENOUS PRIOR TO USE" IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31403 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR BKP