BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2936130 · Received January 30, 2013

    Report

    Report Number
    1020279-2013-00056
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED TO DETERMINE THE CAUSE OF THE REPORTED INCIDENT. A VISUAL AND MACROSCOPIC EXAMINATION WAS PERFORMED. FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE PERI-LOC VLP MTP LOCKING PLATE FRACTURED BY THE INITIATION AND SUBSEQUENT PROPAGATION OF FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE PLATE COULD NOT BEAR THE IMPOSED PATIENT LOADING, WHICH LEAD TO AN OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE PLATE BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO (1) EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, (2) APPLICATIONS OF LOADS IN EXCESS OF THE MATERIAL¿S STRENGTH, AND/OR (3) POOR BONE QUALITY. NO MATERIAL DEVIATIONS IN THE PLATE WERE FOUND DURING THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE DUE TO A BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40537 PLATE PLATE HRS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R