BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPEDE BONE CEMENT

    MDR report key: 8376973 · Received February 28, 2019

    Report

    Report Number
    2953769-2019-00005
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 31, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    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, UDI# (B)(4). 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 UNDERWENT CEMENTOPLASTY PROCEDURE AT T12-L2 DUE TO OSTEOPOROSIS AND VERTEBRAL FRACTURE. INTRA-OP, AFTER SHORT MIXING OF THE CEMENT, THE SURGEON FILLED TH12 (LEFT SIDE) WITH ONE BONE FILLER (1,5CC CEMENT), THEN L2 (LEFT SIDE) WITH ONE BONE FILLER (1 ,5CC CEMENT) AND L2 (RIGHT SIDE) WITH ONE BONE FILLER (1,5CC CEMENT); AFTERWARDS THE SURGEON FILLED L1 (LEFT SIDE) WITH ONE BONE FILLER (1,5CC CEMENT) AND L1 (RIGHT SIDE) WITH ONE BONE FILLER (1,5CC CEMENT). THE FILLING OF L1 NEEDED A LOT OF POWER BEACUSE THE CEMENT WAS HARDENING TOO FAST. THE REMAINING THREE FILLED BONE FILLER COULD NOT BE USED BECAUSE THE CEMENT WAS ALREADY HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172189 KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70086

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR