BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 1981466 · Received February 8, 2011

    Report

    Report Number
    2953769-2011-00007
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE NOT RETURNED; FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE IN (B)(6) 2010. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY AND GOOD PATIENT OUTCOME. THE PATIENT PRESENTED IN (B)(6) 2010 WITH MULTIFOCAL PARASPINAL AND EPIDURAL ABSCESSES. THE INFECTION IS AT THE TREATED LEVEL AND HAS SPREAD TO OTHER LEVELS. PATIENT WAS TREATED WITH IV ANTIBIOTICS. PATIENT'S CURRENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INFLATABLE BONE TAMP HRX MEDTRONIC SPINE LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other