BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 6470884 · Received April 7, 2017

    Report

    Report Number
    2953769-2017-00034
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 14, 2017
    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

    THIS PRODUCT IS NOT APPROVED FOR SALE IN U.S BUT A SIMILAR PRODUCT WITH CATALOG# C01A , 510K# K160983 AND (B)(4) IS APPROVED FOR SALE IN U.S. (B)(4). THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, CEMENT MIGRATED TO THE SEGMENTAL ARTERY. INTRA-OP, A SMALL AMOUNT OF CEMENT LEAKED TO ANTERIOR OF VERTEBRAL BODY DURING INJECTING. THE INJECTION WAS STOPPED AND AFTER THE CEMENT HARDENED, THE REMAINING CEMENT WAS INJECTED CAREFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255362 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL60716

    Patients

    Seq Age Sex Outcome Treatment
    1