BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS CONTRA ANGLE

    MDR report key: 10646088 · Received October 7, 2020

    Report

    Report Number
    8031010-2020-00211
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Report Date
    October 2, 2020
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EGS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    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. RECEIVED - 1X X-SMART PLUS CONTRA-ANGLE 6:1 A103300000000; SN: (B)(4). 1X X-SMART PLUS HANDPIECE A103400000300; SN: (B)(4). 1X X-SMART PLUS UNIV.AC.ADAPTER A103400000200. 1X X-SMART PLUS UNIT SN: (B)(4). X-SMART PLUS BATTERY. DEFECTIVE BATTERY. BATTERY LIFE IS LOW. X-SMART PLUS HEAD CAP. BAD MAINTENANCE (USER). THERE IS SOME FOREIGN MATTER ON THE HEAD CAP. X-SMART PLUS CARTRIDGE; VARIOUS MECHANICAL PROBLEM; FILES CANNOT LOCK BECAUSE HOOK OF CARTRIDGE IS DAMAGED.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A X-SMART PLUS CONTRA ANGLE WON'T HOLD FILES; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106361 X-SMART PLUS CONTRA ANGLE HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1