BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3952092 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06383
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TIBIAL PLATEAU FRACTURE REPAIRMENT PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LOCKING SCREWS WOULD NOT FULLY SET INTO THE TIBIAL PLATE. THE PROCEDURE WAS COMPLETED LEAVING OUT THE PROBLEM SCREWS. THERE WAS NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431174 UNKNOWN PLATE, FIXATION HRS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R