BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SMART PLUS 6:1 CONTRA-ANGLE

    MDR report key: 13862004 · Received March 23, 2022

    Report

    Report Number
    8031010-2022-00481
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Report Date
    September 15, 2022
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    RECEIVED = 1X X-SMART PLUS BEARING RETAINER H1033C1051113. 1X X-SMART PLUS CARTRIDGE H1033C1051015. 1X X-SMART PLUS HEAD ASSEMBLY H1033C1051011 SN: (B)(6). 1X X-SMART PLUS HEAD CAP H1033C1051050. 1X X-SMART PLUS WAVE WASHER H1033C427A360. X-SMART PLUS CARTRIDGE. SAV BAD MAINTENANCE (USER). THERE IS SOME RUST ON THE CARTRIDGE. REPLACED 1X XP CARTRIDGE H1033C1051015. 1X XP BEARING RETAINER H1033C1051113. 1X XP HEAD ASSEMBLY H1033C1051011 1X XP HEAD CAP H1033C1051050. 1X XP WAVE WASHER H1033C427A360.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A X-SMART PLUS 6:1 CONTRA-ANGLE WON'T HOLD FILES. INJURY IS UNKNOWN AT THIS TIME. ADDITIONAL REQUEST FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265653 X-SMART PLUS 6:1 CONTRA-ANGLE HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS MAILLEFER INSTRUMENTS HOLDING SARL 01160054; 01154678

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown