BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERRATED EXODONTIA ELEVATOR #46 R

    MDR report key: 6099225 · Received November 14, 2016

    Report

    Report Number
    0001032347-2016-00663
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Report Date
    October 26, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. VISUAL INSPECTION REVEALED MODERATE USE INCLUDING A FRACTURED TIP. THEREFORE, THE COMPLAINT IS CONFIRMED. THE MOST-LIKELY CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE APPLIED IN AN ATTEMPT TO EXTRACT A TOOTH. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AN ELEVATOR BROKE DURING A PROCEDURE. IT IS REPORTED THAT THE SURGEON WAS ABLE TO PICK THE BROKEN PIECES OF THE INSTRUMENT FROM THE PATIENT WITHOUT ANY SURGICAL INTERVENTION. IT IS REPORTED THE PROCEDURE WAS COMPLETED WITH ANOTHER ELEVATOR. IT IS REPORTED THERE WAS A DELAY OF TWO TO THREE MINUTES TO THE PROCEDURE. IT IS REPORTED NO FOREIGN BODY WAS LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751174 SERRATED EXODONTIA ELEVATOR #46 R ELEVATOR EMJ BIOMET MICROFIXATION N/A 102015J15

    Patients

    Seq Age Sex Outcome Treatment
    1