BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5528510 · Received March 28, 2016

    Report

    Report Number
    2953769-2016-00028
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 1, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K041584 WAS CLEARED IN THE UNITED STATES. 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 FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS; TYPE OF FRACTURE: COMPRESSION FRACTURE. IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY FOR L1 COMPRESSION FRACTURE. DURING SURGERY, CEMENT LEAKED TOWARDS ANTERIOR OF VERTEBRAL BODY DURING INSERTING CEMENT. THE PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. PRODUCT IMPLANTED-REMAINS IN SERVICE PATIENT IS ALIVE-NO INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185615 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL56015

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR