BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BURR 7777 DIA 2.0MM LEMOINE

    MDR report key: 5064851 · Received September 9, 2015

    Report

    Report Number
    2523190-2015-00079
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 26, 2015
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09/15/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. RESULTS: EVALUATION OF RETURNED DEVICE; THE DRILL BIT IS BROKEN. THE FRAGMENT OF ABOUT 1CM LENGTH STAYED IN THE PATIENT. THE MOBILE PART WHICH SCREW HAS NOT BEEN RETURNED. ROD LENGTH, THREADED ROD LENGTH, WASHER KNURLING, PROXIMAL PART FORM AND DRILL BIT ASSEMBLING DO NOT MEET THE MANUFACTURING SPECIFICATIONS. LOT NUMBER AND MANUFACTURING DATE UNKNOWN. CONCLUSION: THIS DEVICE IS NOT AN INTEGRA (MICROFRANCE) INSTRUMENT.

    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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE DRILL BURR FOR LEMOINE DRILL BROKE IN PATIENT SINUS. THERE ARE NO OTHER CONSEQUENCES FOR THE PATIENT, EXCEPT FOR THE BROKEN PART IN THE SINUS. (B)(6) 2015: PATIENT: CANNOT HAVE MRIS. THE SURGEON LEFT THE BROKEN PART IN THE PATIENT BECAUSE THERE WAS A RISK TO DAMAGE THE SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597016 DRILL BURR 7777 DIA 2.0MM LEMOINE PFM11 EQJ INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other