BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX INFLATABLE BONE TAMP

    MDR report key: 1694456 · Received May 12, 2010

    Report

    Report Number
    2953769-2010-00190
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Report Date
    April 15, 2010
    Manufacturer
    KYPHON, INC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED, FOLLOWED UP WITH PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN "EXPERIENCED BALLOON RUPTURE 2-3 TIMES IN CHRONIC STAGES". NO ADDITIONAL INFO WAS REPORTED. NOTE: KYPHOPLASTY PRODUCTS ARE NOT DISTRIBUTED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX INFLATABLE BONE TAMP INFLATABLE BONE TAMP HRX KYPHON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK