BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER - 12MM

    MDR report key: 2891471 · Received December 6, 2012

    Report

    Report Number
    3004608878-2012-00226
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    MAX
    PMA / PMN Number
    K082712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE 2ND OF TWO REPORTS (SAME PATIENT, SAME PROCEDURE, SIMILAR PRODUCTS). THIS REPORT IS IN REGARDS TO PRODUCT ID: 14-40-0012 INSERTER- 12MM. IT WAS REPORTED THAT THE PAINT OF THE INSERTERS WAS CHIPPING WHEN THE MALLET WAS USED ON THEM. THE PAINT FROM THE INSERTER WAS FALLING INTO THE SURGICAL WOUND WHEN BEING USED. THE REPORTER WAS NOT SURE WHICH INSERTER WAS CHIPPING PAINT BECAUSE THE USER WAS TRIALING BACK AND FORTH BETWEEN THE 11MM AND 12MM INSERTERS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTER - 12MM NONE MAX INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1