BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8721142 · Received June 21, 2019

    Report

    Report Number
    2953769-2019-00011
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 21, 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, 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

    PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS. TYPE OF FRACTURE: COMPRESSION FRACTURE. LEVELS IMPLANTED: L1 IT WAS REPORTED THAT INTRA-OP, CEMENT SOLIDIFIED EARLIER THAN EXPECTED BEFORE ENOUGH AMOUNT WAS FILLED IN THE PATIENT BODY. CEMENT WAS STORED AT PROPER TEMPERATURE BEFORE AND DURING THE PROCEDURE I.E (BELOW 25 ° C DURING STORAGE; 23 +/- 1 ° C FOR 24 HOURS PRIOR TO USE). THE CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH THE USE OF NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516587 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70095

    Patients

    Seq Age Sex Outcome Treatment
    1