BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON KYPHOPLASTY

    MDR report key: 2792551 · Received October 16, 2012

    Report

    Report Number
    2953769-2012-00146
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    March 28, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 A LITERATURE ARTICLE, THAT A RETROSPECTIVE STUDY WAS DONE OF 127 PATIENTS WITH LOW-ENERGY VERTEBRAL FRACTURES. 127 PATIENTS WERE INCLUDED WHO RECEIVED TREATMENT AT 138 VERTEBRAL LEVELS. IT WAS REPORTED THAT 43 PATIENTS EXPERIENCED ASYMPTOMATIC CEMENT LEAKAGE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON KYPHOPLASTY ARTHROSCOPE HRX MDT KYPHON SUNNYVALE MFG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1