BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY3 IMPLANT

    MDR report key: 6933515 · Received October 9, 2017

    Report

    Report Number
    3001617766-2017-00009
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    February 17, 2017
    Report Date
    October 9, 2017
    Manufacturer
    IMPLANT DIRECT LLC
    Product Code
    DZE
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVISION: B APPEARANCE: NO IMPLANT RECEIVED. INSPECTION WAS PERFORMED ON THE VIAL P/N P1001-01 REV: D SPECIFICATION SHOULD BE: LENGTH: 1.91 ± .01 SPECIFICATION AS FOUND: 1.9085. DIAMETER: 595 ± .003 SPECIFICATION AS FOUND: .5791/.5934. COMMENTS: RECEIVED A VIAL P1001-01 REV: D, INNER VIAL P1001-02, VIAL CAP P1001-03 AND THE SCREW RETAINER P1001-04. THE VIAL'S SEALING DIAMETER .595 ±.003 IS OUT OF ROUND MEASURING FROM .5791 TO .5934 MAKING IT VERY DIFFICULT FOR THE INNER VIAL TO SLIDE FREELY OUT OF THE VIAL AND POSSIBLY ALSO AFFECTING THE SEALING CAPABILITIES AND COMPROMISING STERILIZATION OF THE COMPONENTS WITHIN. NO LOT CHECK REQUESTED, ALL THE VIALS FROM THIS LOT NUMBER ARE EXHAUSTED FROM OUR INVENTORY. WE SOLD ALL (B)(4) OF THIS LOT WITH NO OTHER COMPLAINTS REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    WHEN THE DENTIST TRIED TO DROP THE IMPLANT ASSEMBLY OUT OF OUTER VIAL, THE INNER VIAL WOULD NOT COME OUT. SO, HE HAD TO HOLD THE INNER VIAL WITH AN ORTHODONTIC PLIER AND TO PULL OUT IT FROM THE OUTER VIAL. THE SURGICAL OPERATION WAS COMPLETED WITH THE IMPLANT FROM THE VIAL. THE INNER CIRCULAR RAIL WHERE CONTACTS THE VIAL EDGE IS DAMAGED: THE CAP CANNOT BE SCREWED ON PROPERLY. THE VIAL EDGE IS DISTORTED AND DOES NOT FORM A COMPLETE CIRCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708022 LEGACY3 IMPLANT LEGACY3 IMPLANT DZE IMPLANT DIRECT LLC 864713 79607

    Patients

    Seq Age Sex Outcome Treatment
    1