BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5117814 · Received September 29, 2015

    Report

    Report Number
    2023950-2015-00161
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    August 5, 2015
    Report Date
    September 29, 2015
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN DID NOT FOLLOW THE USER DOCUMENTATION INSTRUCTIONS, PER TECHNIQUE MANUAL, P/N L8019-TM, REGARDING THE FINAL SEATING TORQUE. WHEN THEY WERE UNABLE TO TORQUE THE IMPLANT TO 30 NCM, THEY SIMPLY REMOVED IT AND REQUESTED A REPLACEMENT IMPLANT. SINCE THE CLINICIAN HAD TO REMOVE THE IMPLANT, THE PT WILL REQUIRE ADDITIONAL SURGICAL INTERVENTION, AT A LATER DATE, TO PLACE A NEW IMPLANT. THE RECORDS MANAGEMENT DATABASE OF EACH OF THE IMPLANTS INDICATES THAT THE IMPLANTS MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ANY ISSUES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE IMPLANTS. NO FURTHER ACTION IS REQUIRED. REFER TO (B)(4).

    Description of Event or Problem · 1

    CLINICIAN REMOVED THE IMPLANT SINCE THEY WERE UNABLE TO TORQUE THE IMPLANT IN PLACE TO THE RECOMMENDED VALUE (30 N-CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642340 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. I0YBJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention