BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8170951 · Received December 17, 2018

    Report

    Report Number
    2953769-2018-00032
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 17, 2018
    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 US BUT A SIMILAR PRODUCT WITH CATALOG# C01A , 510K# K160983 AND UDI# (B)(4) IS APPROVED FOR SALE IN U.S. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, AFTER CEMENT INSERTION, THE CEMENT BACK FLOWED INTO THE PEDICLE. IT WAS UNKNOWN WHETHER IT WAS LATE TO PLUG WITH BFD, AND WHETHER THERE WAS PRESSURE INSIDE THE VERTEBRAL BODY. IT SEEMED THAT THE CEMENT FLOWED BACK EARLY. BEFORE IMPLANTING THE CEMENT, IT WAS MIXED FOR ABOUT 9 MINUTES AND WAS DOUGHY AND HOMOGENEOUS PRIOR TO DELIVERY IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS CONFIRMED DUE TO THIS ISSUE AT THIS POINT AND THE PATIENT'S PRE-OPERATIVE SYMPTOM HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007636 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70060

    Patients

    Seq Age Sex Outcome Treatment
    1