BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHEIN. AUTOCL U CONTRA A

    MDR report key: 4996017 · Received August 6, 2015

    Report

    Report Number
    2523190-2015-00047
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 3, 2015
    Report Date
    August 11, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EFB
    PMA / PMN Number
    K073652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A CONTRA ANGLE WAS RETURNED IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. DEVICE IS SHOWING WEAR, RESIDUE AND BROKEN SCREW TOP. UPON THE EVALUATION OF THE ANGLE IT IS CONFIRMED THAT THE SCREW HAS FALLEN OFF. IT ALSO APPEARS TO HAVE BUILT UP RESIDUE ON THE SCREW AREA. WITHOUT KNOWING HOW THE INSTRUMENT WAS MAINTAINED AND HANDLED, THE CAUSE OF THE COMPLAINT REPORT IS UNDETERMINED. THIS TYPE OF DAMAGE IS TYPICALLY THE RESULT OF IMPROPER PROCESSING. DEVICE HISTORY EVALUATION - DHR REVIEW WAS COMPLETED WITH ALL HISTORY AVAILABLE. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT REPORT HAS BEEN CONFIRMED; THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS SCREW POPPED OFF. ON (B)(6) 2015 DOCTOR USES RUBBER DAM TO PREVENT PT FROM SWALLOWING THINGS, NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520165 SCHEIN. AUTOCL U CONTRA A M51 - GENERAL DENTISTRY EFB INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR