BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 2930286 · Received January 25, 2013

    Report

    Report Number
    1030489-2013-00251
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TSUYOSHI OKUDAIRA, HIROAKI KONISHI, YAMANE HIROTOSHI, TAKESHI HIURA, TAKEMA NAKASHIMA. "OUR TREATMENT EXPERIENCE WITH BALLOON KYPHOPLASTY (BKP) FOR OSTEOPOROTIC VERTEBRAL FRACTURES-CASES OF POOR OUTCOME AND ADJACENT VERTEBRAL FRACTURE". DATE OF EVENT IS UNKNOWN. (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 IN AN ABSTRACT THAT BALLOON KYPHOPLASTY PROCEDURES WERE PERFORMED IN 44 PATIENTS. THE PATIENTS WERE FOLLOWED FOR 6 MONTHS OR MORE (MEAN FOLLOW UP: 10.8 MONTHS). IT WAS REPORTED THAT INTRA-OPERATIVELY, FIVE PATIENTS WERE OBSERVED AS HAVING "CEMENT LEAKAGE OUT OF THE VERTEBRA (N=5, EXCEPT CEMENT LEAKAGE INTO THE SPINAL CANAL)", HOWEVER, NO SEVERE COMPLICATIONS WERE NOTED. NO FURTHER INFORMATION WAS REPORTED. THE TYPE OF CEMENT USED WAS NOT SPECIFIED IN THE ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35174 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP