BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 3100124 · Received May 8, 2013

    Report

    Report Number
    1030489-2013-01606
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    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

    (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) AT L2 FOR PSEUDOATHROSIS FOLLOWING A PRIMARY OSTEOPOROTIC COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CEMENT "LEAKED TO THE PEDICLE AFTER THE INJECTION OF THE CEMENT". IT WAS ALSO REPORTED THAT THE BONE FILLER DEVICE (BFD) WAS ROTATED TO PREVENT FLOW-BACK OF CEMENT BUT IT WAS SUSPECTED THAT THE BFD WAS NOT ROTATED ENOUGH TO PREVENT THE CEMENT EXTRAVASATION INTO THE PEDICLE. THE CEMENT VOLUME WAS 4.0ML WITH 2.0ML ON EACH SIDE OF THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200451 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR BKP