BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM LFT NARROW MANDIBLE

    MDR report key: 3844572 · Received June 3, 2014

    Report

    Report Number
    0001032347-2014-00187
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE DATA AVAILABLE THROUGH THE REVIEW AND INVESTIGATION OF THIS FILE, THE MOST LIKELY UNDERLYING CAUSE OF THE PRODUCT BEING EXPLANTED IS A PATIENT'S PHYSIOLOGICAL CONDITION AND NOT AS A RESULT OF THE IMPLANTS MANUFACTURED BY BIOMET MICROFIXATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. FILE 4 OF 6.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A TMJ REVISION SURGERY OCCURRED DUE TO ANKYLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323922 45MM LFT NARROW MANDIBLE TMJ MANDIBLE LZD BIOMET MICROFIXATION N/A 231850B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization