BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3121727 · Received May 21, 2013

    Report

    Report Number
    2953769-2013-00078
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    February 15, 2012
    Report Date
    April 24, 2013
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT). 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 THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT AN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE AT L4. IT WAS REPORTED THAT CEMENT EXTRAVASATION OCCURRED "OUTSIDE THE VERTEBRAL BODY" DURING THE PROCEDURE. THE PATIENT WAS "ASYMPTOMATIC AND ADDITIONAL INTERVENTION WAS NOT REQUIRED." IT WAS REPORTED THAT "THE CAUSE OF THE EVENT WAS INJURY TYPE OF LOWER END PLATE FRACTURE." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223911 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON SUNNYVALE MFG NA EL35410

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR BKP