BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS

    MDR report key: 20343003 · Received October 1, 2024

    Report

    Report Number
    8031010-2024-00117
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE: RECEIVED = 1X X-SMART PLUS CONTRA-ANGLE 6:1 A103300000000 SN: (B)(6). 1X X-SMART PLUS HANDPIECE A103400000300 SN: (B)(6). 1X X-SMART PLUS MOTOR HANDPIECE STAND A103400000400 1X X-SMART PLUS UNIT SN: (B)(6). 1X X-SMART PLUS UNIV.AC.ADAPTER A103400000200 SN: (B)(6). X-SMART PLUS HEAD ASSEMBLY; SAV NO DEFECT; NO DEFECT.. X-SMART PLUS BATTERY; SAV OTHER; NEEDED TO BE CHARGED. REPLACED 1X XP UNIT (B)(6); 1X XP HANDPIECE A103400000300 (B)(6); 1X XP CONTRA-ANGLE 6:1 A103300000000 (B)(6); 1X XP UNIV.AC.ADAPTER A103400000200 (B)(6); 1X XP MOTOR HANDPIECE STAND A103400000400. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: THE OUTCOME OF THIS EVENT IS THAT THERE IS NO INJURY. SINCE WE HAVE RECEIVED THIS INFORMATION THE 8000-OPN-030 APPLIES WHICH NOW AFTER THIS ADDITIONAL INFORMATION MAKES THIS CASE NON-REPORTABLE. CORRECTING INFORMATION THAT WAS SUBMITTED IN THE INITIAL REPORT: 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 THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE. CORRECTING THIS EVENT FROM REPORTABLE TO NON-REPORTABLE AFTER RECEIVING ADDITIONAL INFORMATION. SINCE THIS IS THE CASE THE 8000-OPN-30 (BUR/FILE DETACHMENT (WALKOUT) WITH DS DENTAL HANDPIECES) APPLIES TO THIS EVENT AND IS NOT REPORTABLE. PLEASE DISREGARD THE INITIAL REPORT.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED X-SMART PLUS WON'T HOLD FILES. 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
    38988 X-SMART PLUS CONTROLLER, FOOT, HANDPIECE AND CORD EBW MAILLEFER INSTRUMENTS HOLDING SARL 01669465,01663339,08492484,084

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown