BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 10293853 · Received July 19, 2020

    Report

    Report Number
    2953769-2020-00015
    Event Type
    Malfunction
    Date Received
    July 19, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 20, 2020
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG#: C01A, 510K#: K160983 AND UDI#: (B)(4) IS APPROVED FOR SALE IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DATE OF IMPLANT: (B)(6) 2020 PRODUCT STATUS: : IMPLANTED-OUT OF SERVICE IT WAS REPORTED THAT ON (B)(6) 2020, INTRA-OP, DURING FILLING THE CEMENT INTO THE BFD FROM THE MIXER, THE CEMENT SOLIDIFIED. SO A NEW MIXER AND NEW CEMENT WERE OPENED FOR DEALING WITH IT. THE OPERATION WAS COMPLETED WITHOUT PROBLEMS AFTER REPLACING THE MIXER AND CEMENT. PRE-OP DIAGNOSIS: OVF PROCEDURE INVOLVED: BKP (BALLOON KYPHOPLASTY) THE CEMENT BECAME SOLID SO QUICKLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757773 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG C01A-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1