BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 X 9MM SD IMF HEX SCREW

    MDR report key: 5409863 · Received February 4, 2016

    Report

    Report Number
    0001032347-2016-00046
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    December 22, 2015
    Report Date
    January 5, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZK
    PMA / PMN Number
    PK983728
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 THREE OF SIX FOR THE SAME EVENT; SEE ALSO 0001032347-2016-00043, 0001032347-2016-00045, 0001032347-2016-00047, 0001032347-2016-00049 AND 0001032347-2016-00050. DEVICE PRODUCT CODE IS DZL.

    Description of Event or Problem · 1

    A TMJ TRACKING CARD WAS RETURNED INDICATING A REVISION OF THE RIGHT MANDIBLE. ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE, HOWEVER NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68378 2.0 X 9MM SD IMF HEX SCREW SCREW DZK BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R