BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVN+

    MDR report key: 20023403 · Received August 21, 2024

    Report

    Report Number
    3009161350-2024-71604
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    September 20, 2023
    Report Date
    August 21, 2024
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS INC.
    Product Code
    DZE
    UDI-DI
    D7682070002P0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN AND INHERENT RISK OF DENTAL IMPLANTS AND IS DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS 1, 2 (SEE E.G., KELLER, 1995; BORNSTEIN, 2008,). PALTOP DENTAL SOLUTIONS INC. PROVIDES IFU WITH ALL IMPLANTS. FAILURE TO OSSEOINTEGRATE AND LOSS OF OSSEOINTEGRATION (IMPLANT MOBILITY) IS IDENTIFIED AS AN ADVERSE REACTION AND IDENTIFIED IN THE LIST OF WARNINGS IN ALL END-OSSEOUS DENTAL IMPLANT LABELING. THE SPECIFIC CAUSE FOR A PARTICULAR COMPLAINT IS OFTEN NOT READILY IDENTIFIED AS THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THESE INCLUDE SYSTEMIC MEDICAL CONDITIONS (UNCONTROLLED DIABETES MELLITUS, AIDS, OSTEOPOROSIS), POOR BONE QUALITY AND QUANTITY OF BONE IN WHICH THE IMPLANT IS IMPLANTED, MEDICATIONS (CORTICOSTEROIDS, BISPHOSPHONATES), HARMFUL HABITS TO HEALING (SMOKING), SECONDARY INFECTION AND/OR SURGICAL TRAUMA, INEXPERIENCED CLINICIAN, IMPROPER SURGICAL TECHNIQUE, OR MOBILITY OF THE IMPLANT LEADS TO ITS REMOVAL OR REPLACEMENT, HENCE DENTAL IMPLANT FAILURE. IN ADDITION, A RATE OF IMPLANT FAILURE THAT DOES NOT AFFECT THE PRODUCTS' RISK ASSESSMENT DOES NOT REQUIRE INVESTIGATION AS IT IS A WELL-KNOWN FAILURE MODE THAT HAS BEEN ADEQUATELY STUDIED IN THE PAST. THE PATIENT HAS BONE LOSS , SWELLING AND A SMOKING HABIT.

    Description of Event or Problem · 0

    FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300416 ADVN+ ADVANCED PLUS IMPLANT SP 3.75X11.5 DZE PALTOP ADVANCED DENTAL SOLUTIONS INC. 20-70002P WO-021976 D7682070002P0

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention