BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHOPLASTY

    MDR report key: 1900480 · Received November 16, 2010

    Report

    Report Number
    2953769-2010-00583
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    HRX
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "EFFICACY AND SAFETY OF BALLOON KYPHOPLASTY IN THE TREATMENT OF OSTEOPOROTIC COMPRESSION FRACTURES WITH RADIOGRAPHIC EVIDENCE OF RETROPULSION: A RETROSPECTIVE STUDY WITH RADIOGRAPHIC, CLINICAL OUTCOME AND TECHNICAL ANALYSIS", BY JOHN F. HAMILTON; JAE Y. LIM; MARIA READ; CHRIS BROWN; KATRINA MANIEC. METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR REFERENCE MFR REPORT #: 2953769-2010-00582 - (B)(4).

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "EFFICACY AND SAFETY OF BALLOON KYPHOPLASTY IN THE TREATMENT OF OSTEOPOROTIC COMPRESSION FRACTURES WITH RADIOGRAPHIC EVIDENCE OF RETROPULSION: A RETROSPECTIVE STUDY WITH RADIOGRAPHIC, CLINICAL OUTCOME AND TECHNICAL ANALYSIS", THE FOLLOWING EVENTS WERE REPORTED: FIFTY PATIENTS UNDERWENT KYPHOPLASTY AT 64 LEVELS. COMPLICATIONS NOTED WERE: -1 TRANSIENT ALTERED MENTAL STATUS -1 SUPRAVENTRICULAR TACHYCARDIA NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHOPLASTY ARTHROSCOPE HRX MEDTRONIC SPINE LLC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Life Threatening