BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE 24GA PRESTRETCH 10/PK 6IN

    MDR report key: 6102830 · Received November 15, 2016

    Report

    Report Number
    0001032347-2016-00668
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    DZL
    PMA / PMN Number
    PK831005
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    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. DEVICE PRODUCT CODE: DZC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE WIRE BROKE DURING A MANDIBLE FRACTURE REPAIR. THE BROKEN WIRE WAS REMOVED AND ANOTHER WIRE WAS USED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754705 WIRE 24GA PRESTRETCH 10/PK 6IN WIRE DZL BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention