BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5528508 · Received March 28, 2016

    Report

    Report Number
    2953769-2016-00029
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 29, 2016
    Report Date
    February 29, 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)(6). (B)(4) (NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT), (NO CODE AVAILABLE FOR "CEMENT EXTRAVASATION"), 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.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS:PRIMARY OSTEOPOROSIS TYPE OF FRACTURE:COMPRESSION FRACTURE IT WAS REPORTED THAT ON (B)(6) 2016,PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, CEMENT LEAKED OUTSIDE OF THE VERTEBRAL BODY. THE LEAKAGE WAS FOUND ONLY AT THE LOWER ENDPLATE DIRECTION. PRODUCTS CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186346 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1