BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2963708 · Received February 15, 2013

    Report

    Report Number
    1030489-2013-00518
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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). 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 (BKP) FOR OSTEOPOROTIC COMPRESSION FRACTURE AT T12. IT WAS REPORTED THAT CEMENT MIGRATED TOWARD THE CAUDAL INTERVERTEBRAL DISC INTRA-OPERATIVELY AND THE PHYSICIAN IMMEDIATELY STOPPED THE FILLING. THE PHYSICIAN COMMENTED THAT THE "CAVITY MIGHT BE TOO MUCH CREATED" AND "THE LEAKAGE WAS TINY AT DISC LEVEL". IT WAS ALSO REPORTED THAT THE CEMENT WAS NOT STORED AT 23 +/-1°C FOR 24 HOURS PRIOR TO USE. CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67336 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP