BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    MDR report key: 6004144 · Received October 6, 2016

    Report

    Report Number
    0001032347-2016-00560
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK113512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. REPORT EIGHT OF EIGHT FOR THE SAME EVENT, REFERENCE 1032347-2016-00553 THROUGH 1032347-2016-00559.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED AFTER HER SON RECEIVED THE IMPLANT, HE CONTINUED TO GROW AND DEVELOP EXCESS BONE IN THE TMJ AREA WHICH FORMED A LARGE BONY MASS WHICH IMPEDED HIS MOUTH OPENING. IN (B)(6) 2015, THE SURGEON REMOVED THE BONY MASS AND IMPLANT FREEING UP MOVEMENT. THE PLAN IS FOR ORTHODONTIC TREATMENT FOLLOWED BY ORTHOGNATHIC SURGERY TO ALIGN HIS BITE BETTER AND IMPROVE AESTHETICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659417 BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES CROSS-DRIVE EMERGENCY SCREW 3.2X10MM HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R