BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCK COMP PL 12H 229MM

    MDR report key: 8181464 · Received December 19, 2018

    Report

    Report Number
    1020279-2018-02839
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 22, 2018
    Report Date
    May 19, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRS
    UDI-DI
    03596010523297
    PMA / PMN Number
    K033669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICE WAS RETURNED AND EVALUATED. THE LAB ANALYSIS CONCLUDED, THE PURPOSE OF THIS INVESTIGATION WAS TO EXAMINE THE RETURNED DEVICE. NO DESTRUCTIVE ANALYSIS WAS CONDUCTED. DUE TO THE SIZE OF THE PLATE, THE FRACTURE SURFACE WAS UNABLE TO BE EVALUATED USING THE SEM. FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, THE EXACT CAUSE OF THE REPORTED FAILURE WAS NOT ABLE TO BE DETERMINED. THE CLINICAL/MEDICAL TEAM CONCLUDED, NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN. THEREFORE BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THE CORRESPONDING PRODUCTS DID NOT REVEAL ANY DEVIATION FROM THE STANDARD MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT HISTORY FOR THE LISTED PART REVEALED NO PRIOR COMPLAINTS FOR THE LISTED BATCH. IF NEW INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT CAN BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY FOR A BROKEN STRAIGHT PLATE, REPLACED BY A 10 HOLE CHS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020482 4.5MM LCK COMP PL 12H 229MM PLATE, FIXATION, BONE HRS SMITH & NEPHEW, INC. 03596010523297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R