BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9101897 · Received September 22, 2019

    Report

    Report Number
    1030489-2019-01051
    Event Type
    Malfunction
    Date Received
    September 22, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 22, 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 #: 00643169097865 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, THE CEMENT SOLIDIFIED WHILE FILLING THE CEMENT. THE SOLIDIFICATION TIME WAS EARLIER THAN THE SURGEON EXPECTED, AND THE DESIRED AMOUNT OF CEMENT COULD NOT BE FILLED. CEMENT WAS MIXED FOR ABOUT 30 SECONDS AND WAS DOUGHY AND HOMOGENEOUS PRIOR TO DELIVERY INTO THE PATIENT. A NEW CEMENT WAS THEN USED TO COMPLETE THE PROCEDURE. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME DUE TO THIS EVENT, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895649 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70110

    Patients

    Seq Age Sex Outcome Treatment
    1