BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 8195764 · Received December 26, 2018

    Report

    Report Number
    9612164-2018-03771
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L DE C.V.
    Product Code
    HXG
    UDI-DI
    00643169143791
    PMA / PMN Number
    K123771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, THE BALLOON DID NOT INFLATE. THE BALLOON WAS INSERTED IN THE CANNULA AND IT RUPTURED DURING INFLATION. THERE WAS NO HOLE IN THE BALLOON PRIOR TO RUPTURE AND THE BALLOON RUPTURED IMMEDIATELY AFTER INFLATION. THE CONTRAST MEDIA WAS LEAKED. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIUM. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF EVENT. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034729 KYPHON EXPRESS II INFLATABLE BONE TAMP TAMP HXG MEDTRONIC MEXICO S. DE R.L DE C.V. NA UNK 00643169143791

    Patients

    Seq Age Sex Outcome Treatment
    1