BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONX IMPLANTS LTD

    MDR report key: 286484 · Received July 19, 2000

    Report

    Report Number
    MW1019328
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    May 31, 2000
    Report Date
    July 6, 2000
    Manufacturer
    BIONX IMPLANTS, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIC BROWLIFT PERFORMED IN 2000, UTILIZING ABSORBABLE SCREWS. SECOND SURGERY ALMOST 6 MONTHS LATER TO REMOVE RETAINED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX IMPLANTS LTD ABSORBABLE SCREWS MAI BIONX IMPLANTS, INC. 852006EB-2 2929

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other