BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 8765250 · Received July 5, 2019

    Report

    Report Number
    3001617766-2019-00297
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 6, 2019
    Report Date
    October 22, 2020
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101338
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B4 FOR REPORT SUBMISSION DATE, G1 FOR CONTACT INFORMATION, G3 FOR AWARENESS DATE OF NEW INFORMATION, G6 FOR REPORT TYPE AND SECTIONS D9, H1, H2, H3, AND H6 TO REPORT THAT THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. INFORMATION FOR SECTION A1, A2, A3, A4 WERE NOT AVAILABLE. WHEN INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), DURING THE CLINICAL PROCEDURE, THE DOCTOR COULD NOT REMOVE THE IMPRESSION POST AND STRIPPED 3 DRIVERS. PER THE COMPLAINT, THE DOCTOR STATES THAT HE DID NOT USE A TORQUE WRENCH TO TIGHTEN SCREW BUT WHEN HE TRIED TO REMOVE THE SCREW FROM THE IMPLANT IT WAS STUCK. HE HAS STRIPPED OR BROKEN MULTIPLE TIPS AND TRIED THE ULTRA SONIC TO TRY TO BREAK UP ANYTHING WEDGING THE ABUTMENT IN PLACE, NOTHING WORKED. ADDITIONALLY, THE DOCTOR HAS APPLIED TO UP TO 60 NCM OF COUNTERCLOCKWISE TORQE AND THE SCREW WOULDN'T MOVE. THE IMPLANT WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557751 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC 824213 104851 10841307101338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention