BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-REAMER

    MDR report key: 6230848 · Received January 6, 2017

    Report

    Report Number
    9611053-2016-00072
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Report Date
    January 6, 2017
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. ONLY UNUSED PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS CASE A CUSTOMER REPORTED THAT A K-REAMER "HANDLE GETS LOOSE FROM THE SHAFT." TREATMENT WAS COMPLETED. THE DENTIST WAS NOT WILLING TO PROVIDE MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11597 K-REAMER REAMER, PULP CANAL, ENDODONTIC EKP DENTSPLY VDW GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1