BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIONX IMPLANT LTD

    MDR report key: 250285 · Received November 9, 1999

    Report

    Report Number
    250285
    Event Type
    Injury
    Date Received
    November 9, 1999
    Date of Event
    November 4, 1999
    Report Date
    November 5, 1999
    Manufacturer
    BIONX IMPLANTS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LT ANKLE ORIF IN 1999. REVISION OF LT ANKLE ORIF LATER IN 1999. THE SYNDESMOTIC SCREW (ABSORBABLE 50MM 4.5MM BIONIC SCREW) HAD BROKEN. REASON FOR 2ND SURGERY, THE ANKLE MORTISE SHOWED WIDENING AND A TALAR SHIFT ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX IMPLANT LTD Implant ABSORBABLE 50MM 4.5MM BIONIC SCREW MAI BIONX IMPLANTS LTD IDJJ8 2418

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R