BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9160278 · Received October 6, 2019

    Report

    Report Number
    1030489-2019-01125
    Event Type
    Malfunction
    Date Received
    October 6, 2019
    Date of Event
    September 6, 2019
    Report Date
    October 6, 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: PRIMARY OSTEOPOROSIS TYPE OF PROCEDURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, WHILE THE CEMENT WAS BEING FILLED INTO L1 VERTEBRAL BODY, THE IMAGING REVEALED THAT THE CEMENT SLIGHTLY LEAKED OUT TO THE ANTERIOR SIDE OF THE VERTEBRAL BODY. THE PROCEDURE WAS HOWEVER COMPLETED WITH THE SAME CEMENT; AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954424 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1