BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4348861 · Received December 20, 2014

    Report

    Report Number
    2953769-2014-00177
    Event Type
    Injury
    Date Received
    December 20, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AN ARTICLE ENTITLED "RADIOFREQUENCY (RF) KYPHOPLASTY IN COMPARISON TO (BKP) BALLOON KYPHOPLASTY: A PROSPECTIVE EVALUATION" THAT A PROSPECTIVE EVALUATION OF 99 (68 FEMALES AND 31 MALES) WITH 152 OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES WERE TREATED WITH RFK USING THE STABILIT VERTEBRAL AUGMENTATION SYSTEM ((B)(6)). THREE MONTHS FOLLOW UP IN 85 PATIENTS (59 FEMALES AND 26 MALES) WITH 128 TREATED VCFS ARE REPORTED; 127 (73 FEMALES AND 49 MALES) UNDERWENT 202 BKP PROCEDURES. CEMENT LEAKAGE WAS NOTED IN 7 OF THE RFK PATIENTS AND CEMENT LEAKAGE WAS NOTED IN 21 OF THE BKP PATIENTS. NO SYMPTOMATIC CEMENT LEAKS OR SERIOUS ADVERSE EVENTS WERE SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839357 UNK HRX MDT KYPHON NEUCHATEL MFG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1