BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXODONTIA ELEVATOR #46R SERRATED

    MDR report key: 5531592 · Received March 29, 2016

    Report

    Report Number
    0001032347-2016-00144
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Report Date
    March 1, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR REPORTED THE PART NUMBER AS 09-0527 #301 ELEVATOR, HOWEVER THE PART NUMBER IS 09-0252 #46R ELEVATOR.(B)(4).

    Additional Manufacturer Narrative · 1

    ALL DEVICES REPORTED FOR THIS COMPLAINT FILE WERE RETURNED FOR EVALUATION. ACCORDING TO THE EVALUATION, THE COMPLAINT WAS CONFIRMED AS THE TIP OF THE ELEVATOR WAS FRACTURED OFF. THE MOST-LIKELY, UNDERLYING CAUSE WAS DETERMINED TO BE EXCESSIVE FORCE. THE INSTRUCTIONS FOR USE STATE, "AVOID UNDUE STRESS OR STRAIN WHEN HANDLING." THE NON-CONFORMANCE DATABASE WAS REVIEWED IN THE EVALUATION AND NO NON-CONFORMANCE WAS FOUND FOR THIS LOT. THERE ARE NO INDICATION OF MANUFACTURING DEFECTS. THIS IS SUPPLEMENTAL REPORT 2 OF 4 FOR THE SAME EVENT. REPORTS 1, 3, & 4 ARE REPORTED ON MFR #0001032347-2016-00143-2, 0001032347-2016-00145-2, & 0001032347-2016-00146-2.

    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. REPORT TWO OF FOUR FOR THE SAME COMPLAINT; SEE ALSO 0001032347-2016-00143, 00145 AND 00146.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED FOUR ELEVATORS FROM A FACILITY WERE BROKEN AT THE TIPS DURING A PROCEDURE. ALL PARTS WERE RETRIEVED DURING THE PROCEDURES. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187229 EXODONTIA ELEVATOR #46R SERRATED ELEVATOR EMJ BIOMET MICROFIXATION N/A 497920

    Patients

    Seq Age Sex Outcome Treatment
    1