BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER

    MDR report key: 8512881 · Received April 15, 2019

    Report

    Report Number
    9612164-2019-01312
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 16, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THERE IS A PINE HOLE OF THE BALLOON ON THE MEDIAL PEAK. THIS TYPE OF FAILURE IS CONSISTENT WITH CONTACT WITH BONE SPLINTER WHILE THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. 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 FRACTURES PROCEDURE: BALLOON KYPHOPLASTY LEVELS IMPLANTED: L3-L4 IT WAS REPORTED THAT INTRA-OP, INFLATABLE BONE TAMP RUPTURED AT 80 PSI DURING INFLATION. VOLUME OF THE BALLOON WAS 1 CC PRIOR TO RUPTURE. AFTER THE BALLOON BURST, THE BALLOON WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. X-RAY IMAGE SHOWED THAT JUST AFTER BALLOON BURSTING, DISTRIBUTION OF RADIOPAQUE SUBSTANCE WAS CLEARLY SEEN. NO FRAGMENT OF THE RUPTURED BALLOON REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306252 KYPHON XPANDER ARTHROSCOPE HRX MEDTRONIC MEXICO NA 0009298663

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR