BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 11613087 · Received April 5, 2021

    Report

    Report Number
    9612164-2021-01308
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 5, 2021
    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

    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. DATE REC¿D BY MFR: PRODUCT IS NOT MARKETED IN US. 510(K) FOR SIMILAR PRODUCT MARKETED IN US WITH CATALOGUE # KPX203RB IS K101864. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF OSTEOPOROSIS. IT WAS REPORTED THAT INTRA-OP, AS SOON AS THE CEMENT IS PRESSED INTO THE BONEFILLER, IT EMERGES AGAIN ON THE SIDES OF THE MULTITAP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE IS DELAY OF 15MIN IN OVERALL PROCEDURE TIME. PRODUCT DID NOT COME IN CONTACT WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511381 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KPX203RB-C 221376511

    Patients

    Seq Age Sex Outcome Treatment
    1