BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 9742900 · Received February 23, 2020

    Report

    Report Number
    9612164-2020-00843
    Event Type
    Malfunction
    Date Received
    February 23, 2020
    Date of Event
    January 24, 2020
    Report Date
    March 27, 2020
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KX153, 510K # K101864 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 DIAGNOSED WITH COMPRESSION FRACTURE AT L2; AND UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, WHILE PERFORMING THE PROCEDURE, THE SURGEON NOTICED A LEAKAGE ON X-RAY WHILE HE STARTED TO INFLATE BALLOONS INSIDE THE PATIENT VERTEBRAL BODY. WHEN HE TRIED TO REPLACE THE BALLOON, ALL THE AVAILABLE INFLATABLE BONE TAMPS (IBTS) IN THE STOCK OF THE HOSPITAL WERE ALREADY PIERCED IN THE PACKAGING. AS ALL AVAILABLE IBTS WERE DEFECTIVE, IT WAS IMPOSSIBLE TO PERFORM THE PLANNED BALLOON KYPHOPLASTY. HENCE, SIMPLE VERTEBROPLASTY WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 1

    AFTER THE SALES REP COLLECTED THE ALLEGED PRODUCT FROM THE HOSPITAL AND CHECKED THE PRODUCT HIMSELF, HE FOUND THAT THE PRODUCT WAS NOT DEFECTIVE AT ALL. THE INFLATABLE BONE TAMP (IBT) WORKED PRETTY WELL. IT WAS DETERMINED THAT THE NURSE HAD NOT CONNECTED THE PUMP TO THE BLUE CONNECTOR OF THE IBT; AND INSTEAD, SHE REMOVED THE INNER STYLET OF THE IBT AND PLUGGED THE PUMP ON IT. BECAUSE OF THIS BAD CONNECTION, SHE WAS UNABLE TO INFLATE THE IBT AND THE WATER DIRECTLY CAME OUT THE EDGE OF THE IBT. THE SURGEON AND THE 'OR' MANAGER AGREED WITH THE SALES REP'S OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206134 KYPHON XPANDER II INFLATABLE BONE TAMP HRX MEDTRONIC MEXICO NA 0009487083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention