BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 2162762 · Received July 14, 2011

    Report

    Report Number
    2953769-2011-00085
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    KK981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CASE STUDY THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE. POSTOPERATIVELY, THREE LATERAL X-RAYS SHOWED COLLAPSE OF VERTEBRAL BODY WITH COLLAPSE OF BONE BETWEEN TWO BONE CEMENT CONCENTRATIONS. REDUCTION IS SUBSEQUENTLY LOST. PATIENT HAD PAIN AFTER TREATMENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other