BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 9155114 · Received October 4, 2019

    Report

    Report Number
    2953769-2019-00015
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 4, 2019
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K180700 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. 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 BALLOON KYPHOPLASTY (BKP) AT L1 DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). INTRA-OP, CEMENT SOLIDIFIED. CEMENT WAS STORED AT PROPER TEMPERATURE(S) BEFORE AND DURING THE PROCEDURE (BELOW 25 ° C DURING STORAGE; 23 +/- 1 ° C FOR 24 HOURS PRIOR TO USE). CEMENT MIXING TIME WAS 30 SECONDS. CEMENT CONDITION WAS APPROPRIATE BEFORE BEING INJECTED INTO THE PATIENT. THE MALFUNCTIONED CEMENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950655 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70085

    Patients

    Seq Age Sex Outcome Treatment
    1