BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 9573596 · Received January 10, 2020

    Report

    Report Number
    2953769-2020-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 9, 2020
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    UDI-DI
    00763000025601
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 UNDERWENT KYPHOPLASTY AT THORACIC DUE TO OSTEOPOROTIC VERTEBRAL FRACTURE (OVF). INTRA OP, BALLOON OF INFLATABLE BONE TAMPS (IBT) WAS RUPTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38253 ARTHROSCOPE ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA UNK 00763000025601

    Patients

    Seq Age Sex Outcome Treatment
    1