BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUGGER 1-2

    MDR report key: 16334295 · Received February 9, 2023

    Report

    Report Number
    8031010-2023-00741
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Report Date
    February 14, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED : NO INJURY OCCURRED. ALL BROKENT PARTS WERE REMOVED FROM PATIENT'S MOUTH, NO FURTHER MEDICAL/SURGICAL TREATMENT NECESSARY. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE -4580. HEALTH EFFECT - IMPACT CODE - 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 2199.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. NO PRODUCT AND NO LOT# AVAILABLE. NO INVESTIGATION OR DHR REVIEW CAN BE DONE. ROOT CAUSES ARE NOT DETERMINED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT PLUGGER 1-2 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169310 PLUGGER 1-2 PLUGGER, ROOT CANAL, ENDODONTIC EKR MAILLEFER INSTRUMENTS HOLDING SARL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown