BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPEDE BONE CEMENT

    MDR report key: 9283367 · Received November 6, 2019

    Report

    Report Number
    1030489-2019-01273
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 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
    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 #: K102397 AND UDI #: (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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 INTRA-OP, CEMENT SWELLED FROM LATERAL CLOSURES OF THE MIXER HENCE THE CEMENT COULD NOT BE USED COMPLETELY IN THE PROCEDURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080674 KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 216361773

    Patients

    Seq Age Sex Outcome Treatment
    1