BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL RING 180MM

    MDR report key: 3794157 · Received May 6, 2014

    Report

    Report Number
    1020279-2014-00300
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    LYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS SHOWN THAT THE TAYLOR SPATIAL RING MOST LIKELY FRACTURED BY MECHANICAL OVERLOAD. A FRACTURE CAN OCCUR IF THE MECHANICAL LOAD APPLIED TO THE DEVICE EXCEEDED THE STRENGTH OF THE MATERIAL.

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272367 FULL RING 180MM LYT SMITH & NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R