BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW

    MDR report key: 3962452 · Received July 29, 2014

    Report

    Report Number
    0001032347-2014-00226
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK081067
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON IS PERFORMING A REVISION SURGERY ONLY DUE TO COSMETIC REPAIR AND RECONSTRUCTION FOR THE PATIENT. THERE IS NO INDICATION THAT THE UNIT DID NOT FUNCTION AS DESIGNED OR INTENDED. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. FILE 1 OF 2.

    Description of Event or Problem · 1

    BIOMET (B)(4) REPORTED A PLANNED REVISION SURGERY FOR COSMETIC REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442112 BONE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization