BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS¿ II INFLATABLE BONE TAMP

    MDR report key: 13304550 · Received January 20, 2022

    Report

    Report Number
    9612164-2022-00274
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 29, 2021
    Report Date
    January 20, 2022
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# KEX152EB, 510K # K123771 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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 · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY DUE TO OSTEOPOROTIC FRACTURE. IT WAS REPORTED THAT DURING A KYPHOPLASTY PROCEDURE BOTH BALLOONS RUPTURED AT LESS THAN THE MAXIMUM PRESSURE AND VOLUME ALLOWED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67605 KYPHON EXPRESS¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KEX202EB-INT 223334963

    Patients

    Seq Age Sex Outcome Treatment
    1 Male