BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMAL CAR. D/E LGE/JUM STE

    MDR report key: 6951810 · Received October 16, 2017

    Report

    Report Number
    2523190-2017-00107
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 22, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EKI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    10/3/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A CARRIER WAS RETURNED IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. IT WAS NOTICED THAT THE LEVER IS BROKEN AND THE BARREL IS DETACHED. THE COMPLAINT REPORT IS CONFIRMED; DAMAGED WORN. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS BROKEN LEVERS AND TIPS. NO PATIENT INJURY. (B)(6) 2017 CUSTOMER REPORTS THE LEVER BROKE WHEN FILLING A MOLAR AND FELL INTO PATIENTS MOUTH, PIECE WAS RETRIEVED, NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730166 AMAL CAR. D/E LGE/JUM STE M51 - GENERAL DENTISTRY EKI INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR