BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 8952870 · Received August 31, 2019

    Report

    Report Number
    9612164-2019-03673
    Event Type
    Malfunction
    Date Received
    August 31, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 31, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KX203, 510K # K101864 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

    PRE-OPERATIVE DIAGNOSIS: VERTEBRAL COMPRESSION FRACTURE (VCF) "LWK 1" TYPE OF PROCEDURE: BALLOON KYPHOPLASTY LEVELS OPERATED: 3 IT WAS REPORTED THAT INTRA-OP, THE BALLOON COULD NOT BE INFLATED BECAUSE THE INFLATABLE BONE TAMP (IBT) WAS LEAKING AT THE Y-JUNCTION (ON THE SHAFT OF THE IBT). A NEW PRODUCT WAS THEN USED TO COMPLETE THE PROCEDURE. 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
    746622 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1