BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTR FCPS, GRIP DEEP 151

    MDR report key: 4093174 · Received August 21, 2014

    Report

    Report Number
    2523190-2014-00055
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    April 15, 2014
    Report Date
    July 24, 2014
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION: METHODS: EVAL OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: INVESTIGATION RESULTS: THE RETURNED FORCEPS SHOWING WEAR, DISCOLORATION, AND STAINING. THE FORCEPS GRIP AREA APPEARS TO HAVE MINIMAL CORROSION. THE COMPLAINT IS A CUSTOMER PREFERENCE ISSUE THE END USER DOES NOT PREFER THE DESIGN OF THE FORCEPS. FORCEPS DIMENSIONS ARE WITHIN SPECIFICATIONS. THE COMPLAINT IS UNCONFIRMED. DHR REVIEW WAS COMPLETED WITH ALL HISTORY AVAILABLE VARIANCE AUTHORIZATION/DEVIATION HISTORY: NONE. THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVAL HISTORY: NONE. TREND ANALYSIS: 2 COMPLAINTS OF THIS NATURE WERE IDENTIFIED. CONCLUSION: THERE WERE TWO EXTRACTING FORCEPS, MANUFACTURED IN DECEMBER 2007, RETURNED IN USED CONDITION. FORCEPS DIMENSIONS ARE WITHIN SPECIFICATIONS. THE COMPLAINT IS UNCONFIRMED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE DEVICE WAS NOT WORKING PROPERLY. ON (B)(6) 2014, DOCTOR REPORTS THE DEVICE BROKE THE TOOTH OFF BECAUSE OF UNEVEN GRIP AT THE BASE OF THE TOOTH. DOCTOR HAD TO CUT THE TOOTH OUT, NO HARM TO PT, NO EXCESS BLEEDING. EVENT OCCURRED IN APRIL OR MAY. NO OTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506795 EXTR FCPS, GRIP DEEP 151 M51 - GENERAL DENTISTRY EMG INTEGRA YORK, PA INC 00266578

    Patients

    Seq Age Sex Outcome Treatment
    1