BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8740937 · Received June 27, 2019

    Report

    Report Number
    1030489-2019-00672
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE (CLEFT INSIDE THE VERTEBRAL BODY) IT WAS REPORTED THAT INTRA-OP, 12 MINUTES AFTER CEMENT MIXING, CEMENT FILLING WAS STARTED. AFTER FILLING 2CC OF CEMENT, THE CEMENT SOLIDIFIED AND BECAME UNUSABLE. THE LEFTOVER CEMENT WAS DISCARDED AND ANOTHER CEMENT AND ANOTHER SET WERE OPENED TO PERFORM ADDITIONAL FILLING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532634 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70085

    Patients

    Seq Age Sex Outcome Treatment
    1