BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5069929 · Received September 11, 2015

    Report

    Report Number
    2953769-2015-00127
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    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)(6). (B)(4). PMA 510(K): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BKP AT TH8 AND 10 LEVELS FOR MULTIPLE MYELOMA. DURING THE SURGERY, A SMALL AMOUNT OF BONE CEMENT LEAKED OUTSIDE OF THE VERTEBRAL BODY AT TH8. CEMENT WAS LEAKED FROM THE LATERAL(RIGHT SIDE) WALL OF THE VERTEBRAL BODY AT TH8. THE EVENT DID NOT EXTEND THE SURGICAL TIME. SURGEON COMMENTED THAT THE CEMENT DID NOT LEAK INTO THE VEIN; IT LEAKED A LITTLE DUE TO THE DEFECT AT THE LATERAL WALL OF THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603363 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL50614

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR