BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2991135 · Received March 6, 2013

    Report

    Report Number
    2953769-2013-00037
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    May 12, 2011
    Report Date
    February 6, 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). 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 COMPRESSION FRACTURE AT TH12. X-RAYS WERE TAKEN IMMEDIATELY POST-OP THAT SHOWED "SLIGHT CEMENT LEAKAGE OUTWARD VERTEBRAL BODY." ACCORDING TO THE REPORT, THE PATIENT WAS ASYMPTOMATIC, AND ADDITIONAL INTERVENTION WAS NOT REQUIRED. THE PATIENT WAS DISCHARGED FIVE DAYS POST-OP. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95642 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON SUNNYVALE MFG NA EL35410

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR BKP