BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETER PHARYNGEAL DISSECTOR

    MDR report key: 2061863 · Received April 19, 2011

    Report

    Report Number
    1032347-2011-00054
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GDI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW OF INSTRUMENT SHOWS DINGS AND GASHES ON BOTH WORKING ENDS. 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. HOSPITAL SUBMITTED MDR ALSO, SEE TRIAGE UNIT SEQUENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE FOR A ZYGOMATIC COMPLEX FRACTURE AND REPAIR OF RIGHT ORBITAL FLOOR, 2MM TIP OF DEVICE BROKE OFF INTO SOFT TISSUE UNDERNEATH THE BONE. AT THIS TIME, UNABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETER PHARYNGEAL DISSECTOR DISSECTOR GDI BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR