BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-REAMER

    MDR report key: 3040501 · Received February 15, 2013

    Report

    Report Number
    9611053-2013-00002
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS (THOUGH INADVISABLE PER EXPERT OPINION PROVIDED BY DR. (B)(6)) TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT; THEREFORE, IS REPORTABLE PER 21 CFR PART 803. THE PACKAGE OF FILES WAS RETURNED WITHOUT THE BROKEN FILE. THE RETURNED FILES WERE EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    INT THIS EVENT IT WAS REPORTED THAT A K-REAMER SEPARATED; THE SEPARATED PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69541 K-REAMER EKP DENTSPLY VDW GMBH 024423

    Patients

    Seq Age Sex Outcome Treatment
    1