BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS BURR

    MDR report key: 11626062 · Received April 7, 2021

    Report

    Report Number
    3010470577-2021-03061
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 2, 2021
    Manufacturer
    IN2BONES SAS
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OSTEOTOMY OF THE FOOT, TWO PERCUTANEOUS BURRS USED TO WORK ON THE BONE BROKE. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524854 PERCUTANEOUS BURR PERCUTANEOUS BURR GFF IN2BONES SAS G01 01512 2001089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other