BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM

    MDR report key: 3770876 · Received April 24, 2014

    Report

    Report Number
    0001032347-2014-00144
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    September 18, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE TMJ TRACKING COORDINATOR HAS REACHED OUT TO THE SURGEON'S OFFICE FOR CONFIRMATION, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A REVISION SURGERY TO REMOVE TMJ IMPLANTS DUE TO CHRONIC INFECTION AND INFLAMMATION VIA THE TMJ PATIENT TRACKING LETTER. FILE FIVE OF FIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248461 LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM 2.7X10MM HT X-DRIVE SCREW JEY BIOMET MICROFIXATION N/A 492590

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R