BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 6943402 · Received October 12, 2017

    Report

    Report Number
    2953769-2017-00106
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 13, 2017
    Report Date
    September 13, 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

    PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K160983 AND UDI#: (B)(4) 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY PROCEDURE ON T12 DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. BONE CEMENT WAS INJECTED INTO VERTEBRA WITH THE IMAGE CHECKED TO ENSURE THAT THE CEMENT WOULDN¿T BE INSERTED INTO THE AREA OTHER THAN VERTEBRA. SUBSEQUENTLY, WHEN BFD WAS INSERTED AND CURING WAS AWAITED, THE CEMENT INJECTED INTO THE VERTEBRA FLEW BACK TO THE PEDICLE. IT OCCURRED POSSIBLY BECAUSE THE BFD WAS NOT FULLY INSERTED. BONE FILLER DEVICE AND OSTEO INTRODUCER WERE TURNED SO THAT THEY DO NOT STICK TO EACH OTHER, AND THE EVENT WAS TURNED OUT BY CONFIRMING THE FINAL IMAGE AFTER REMOVAL THE INSTRUMENTS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723285 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL62216

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR