BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R-PILOT, 6X, STERILE (25MM)

    MDR report key: 8621690 · Received May 17, 2019

    Report

    Report Number
    9611053-2019-00137
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKS
    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 WITH A SIMILAR DEVICE 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 INVOLVED R-PILOT 25MM IS ACTUALLY BROKEN AT THE TIP OF THE ACTIVE PART (TORQUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. UNUSED PRODUCT HAS BEEN EVALUATED ACCORDING TO OUR PRESCRIPTIONS AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS (MEASURES, TORQUE TEST). NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1555813, 1555815). ROOT CAUSES ARE NOT IDENTIFIED. THIS KIND OF EVENT IS TRACKED AND WE MONITOR THE TREND.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A R-PILOT BROKE DURING USE. THE BROKEN PART REMAINED IN ROOT CANAL AND TOOTH WAS FILLED WITH BROKEN PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414976 R-PILOT, 6X, STERILE (25MM) FILE, PULP CANAL, ENDODONTIC EKS DENTSPLY VDW GMBH NA 277972

    Patients

    Seq Age Sex Outcome Treatment
    1