BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXODONTIA ELEVATOR #46R SERRATED

    MDR report key: 5531595 · Received March 29, 2016

    Report

    Report Number
    0001032347-2016-00145
    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

    (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. 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 3 OF 4 FOR THE SAME EVENT. REPORTS 1, 2, & 4 ARE REPORTED ON MFR #0001032347-2016-00143-2, 0001032347-2016-00144-2, & 0001032347-2016-00146-2.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR REPORTED THE PART NUMBER AS 09-0527 #301 ELEVATOR, HOWEVER THE PART NUMBER IS 09-0252 #46R ELEVATOR. CATALOG NUMBER WAS UPDATED FROM 09-0257 TO 09-0252. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME COMPLAINT, SEE ALSO 0001032347-2016-00143-1, 00144-1 AND 00146-1.

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2016, THE DEVICE MANUFACTURING DATE WAS UPDATED TO REFLECT JUL 29, 2015.

    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 THREE OF FOUR FOR THE SAME COMPLAINT; SEE ALSO 0001032347-2016-00143, 00144 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
    189371 EXODONTIA ELEVATOR #46R SERRATED ELEVATOR EMJ BIOMET MICROFIXATION N/A 072915G15

    Patients

    Seq Age Sex Outcome Treatment
    1