BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBIDE BURS - FG 557SU PACK OF 10

    MDR report key: 3928561 · Received June 9, 2014

    Report

    Report Number
    2523190-2014-00034
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TIP BROKE INSIDE TOOTH FOUND ON X-RAY BY DOCTOR. DOCTOR THREW THE BUR AWAY. NO PRODUCT WILL BE SENT IN. ON (B)(6) 2014 DOCTOR REPORTS HE WAS PERFORMING ORAL SURGERY, USING THE BUR TO ENLARGE AREA AROUND THE TOOTH WHEN THE BURR BROKE. NO WAY TO KNOW IF THE PATIENT WILL HAVE FUTURE ISSUES BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334386 CARBIDE BURS - FG 557SU PACK OF 10 M51 - GENERAL DENTISTRY EMJ INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1