BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3009161350-2025-70210

    MDR report key: 21133784 · Received January 12, 2025

    Report

    Report Number
    3009161350-2025-70210
    Event Type
    Injury
    Date Received
    January 12, 2025
    Date of Event
    December 7, 2021
    Report Date
    January 12, 2025
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS LTD
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    505

    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 SYSTEMS1, 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, UNEXPERIENCED 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.

    Description of Event or Problem · 0

    FAILED TO OSSEOINTEGRATE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511991 DZE PALTOP ADVANCED DENTAL SOLUTIONS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention