BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORAL SURGICAL BURS - FG EXTRA LONG /SURGICAL ROUND END, 5/PKG

    MDR report key: 9279606 · Received November 4, 2019

    Report

    Report Number
    MW5090872
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 31, 2019
    Manufacturer
    UNK
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    FAILURE OF THE 557 SURGICAL BURS - BURS ARE BREAKING AT THE NECK / HEAD AREA WITH THE SHANK INTACT. PATTERSON COMPANIES, INC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070792 ORAL SURGICAL BURS - FG EXTRA LONG /SURGICAL ROUND END, 5/PKG BUR, DENTAL EJL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1