BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYMIC

    MDR report key: 17596228 · Received August 22, 2023

    Report

    Report Number
    3009161350-2023-70001
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    October 31, 2022
    Report Date
    July 31, 2023
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS INC.
    Product Code
    DZE
    UDI-DI
    D76821700080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    PALTOP DENTAL SOLUTIONS INC. PROVIDES LABELING 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 ENDOSSEOUS 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 PATIENT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES, AND UNCONTROLLED HYPERTENSION. TECHNIQUE FACTORS SUCH AS OVERHEATING OF THE IMPLANT SITE MAY CAUSE NECROSIS OF THE BONE, PREVENTING GROWTH (PELAYO ET AL., 2008; TURKYILMAZ & AL., 2008). PATIENT HABITS SUCH AS TOBACCO USE (HEITZ-MAYFIELD & HUYNH-BA, 2009), ALCOHOL OR DRUG ABUSE, POOR ORAL HYGIENE, AND BRUXISM (SALVI & BRAEGGER, 2009) MAY ALSO LEAD TO IMPLANT FAILURE. IN ADDITION, IMPROPER SURGICAL TECHNIQUE CAN LEAD TO IMPLANT FAILURE AND/OR LOSS OF SUPPORTING BONE (SALVI & BRAEGGER, 2009).

    Description of Event or Problem · 0

    FAIL TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56692 DYMIC DYNAMIC IMPLANT SP 4.2X11.5 DZE PALTOP ADVANCED DENTAL SOLUTIONS INC. 21-70008 WO-018792 D76821700080

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention