BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 7801828 · Received August 21, 2018

    Report

    Report Number
    3001617766-2018-00200
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    June 27, 2018
    Report Date
    August 30, 2018
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101994
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), THE HT2.5 TOOL BECAME STUCK IN THE IMPLANT. THIS RESULTED IN THE REMOVAL OF THE IMPLANT.

    Description of Event or Problem · 1

    REVIEWED ATTACHED CUSTOMER FEEDBACK FORM CONTRAINDICATIONS RELEVANT TO FAILURE: N/A PART: 853210 REVISION: A VISUAL: IMPLANT RECEIVED WAS DAMAGED. SPECIFICATION SHOULD BE: LENGTH: 404 ± .003 SPECIFICATION AS FOUND: .4053 DIAMETER: .1250 / .1265 SPECIFICATION AS FOUND: .1260 COMMENTS: RECEIVED ONLY THE IMPLANT, CUSTOMER DID NOT RETURNED THE HEX TOLL (DRIVER). THE IMPLANT WAS DAMAGED AROUND THE EXTERNAL THREADS AND ALSO AROUND THE INTERNAL HEX FEATURES, VERIFIED THE 2 DIFFERENT HEX SIZE IN THE IMPLANT AND THEY BOTH STILL ACCEPTED OUT HEX GAGE. PERFORMED A VISUAL AND DIMENSIONAL INSPECTION ON THE AREAS NOT AFFECTED BY THE DAMAGED AND IT MEETS OUR SPECIFICATIONS. DATE OF INSPECTION: (B)(4) 2018,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642140 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC 110698 10841307101994

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR