BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN I ONLAY ASYM

    MDR report key: 3840294 · Received May 30, 2014

    Report

    Report Number
    1020279-2014-00334
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING A REVISION SURGERY WAS NOT PERFORMED. THE WIRE FRAGMENT WAS REMOVED DURING INITIAL SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 MONTHS AFTER THE INITIAL SURGERY, THE PATIENT FELT ACUTE INTERNAL PAIN. THE COMPLETE ANALYSIS REVEALED THAT THE METALLIC WIRE HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318553 GEN I ONLAY ASYM GEN TIB PLY OLAY S LM/RL 9MM JWH SMITH & NEPHEW, INC. 03LM07405

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention