BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROOT CANAL INSTRUMENT

    MDR report key: 1585971 · Received January 25, 2010

    Report

    Report Number
    8030962-2010-00001
    Event Type
    Other
    Date Received
    January 25, 2010
    Date of Event
    August 28, 2009
    Report Date
    January 11, 2010
    Manufacturer
    MICRO-MEGA SA
    Product Code
    EKS
    PMA / PMN Number
    K970649
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REGISTERED IN USA (FDA (K970649), BUT IN FACT, THIS FAMILY OF PRODUCT IS NOT SOLD IN THE US MARKET. THE CAUSE OF THE EVENT COULD BE THAT A HIGH EFFORT HAS BEEN APPLIED TO THE INSTRUMENT DURING THE TREATMENT. ENCLOSED DOCUMENT: REPORT TO (B)(6), ANSWER COMING FROM (B)(6) WHICH CLOSED THE INCIDENT.

    Description of Event or Problem · 1

    DURING ROOT CANAL PROCEDURE, A ROTARY FILE SEPARATED. THE SHANK OF THE FILE SEPARATED FROM THE LATCH GRIP COMPONENT. THE PATIENT HAS NO INJURIES BECAUSE, THE BLADE WAS REMOVED EASILY FROM THE TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROOT CANAL INSTRUMENT HERO 6 4 2 EKS MICRO-MEGA SA NO. 30 LENGTH 25 061708

    Patients

    Seq Age Sex Outcome Treatment
    1