BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 6568442 · Received May 16, 2017

    Report

    Report Number
    2953769-2017-00059
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 21, 2017
    Report Date
    April 21, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    UDI-DI
    00643169097865
    PMA / PMN Number
    K041584
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS:PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE LEVELS IMPLANTED: T12 IT WAS REPORTED DURING A POST-OP X-RAY THAT THE CEMENT GOT LEAKED INTO THE SEGMENTAL VEIN. THE SURGEON STARTED FILLING CEMENT IN THE VERTEBRAL BODY AFTER THE VISCOSITY OF CEMENT BECAME APPROPRIATE. CEMENT WAS FILLED IN 6ML FOR T12 OSTEOPOROTIC VERTEBRAL FRACTURE (OVF). THE SURGERY PROCEEDED WITHOUT PROBLEM AND THE INCISION WAS CLOSED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350206 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK 00643169097865

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR