BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPEDE BONE CEMENT

    MDR report key: 8649463 · Received May 29, 2019

    Report

    Report Number
    1030489-2019-00588
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # CX01B, 510K #K163032 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 WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL BODY FRACTURE; AND UNDERWENT KYPHOPLASTY. INTRA-OP, DURING CEMENT INJECTION, A SMALL CEMENT LEAKAGE ON THE LEFT LATERAL SIDE OF THE VERTEBRA BODY WAS OBSERVED. THERE WAS DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442528 KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 217072862

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR