BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLMAX

    MDR report key: 19152659 · Received April 22, 2024

    Report

    Report Number
    3005990499-2024-70731
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 22, 2024
    Manufacturer
    KEYSTONE DENTAL, INC.
    Product Code
    DZE
    UDI-DI
    D76815712K0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KEYSTONE DENTAL 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).KEYSTONE DENTAL 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

    FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389438 TLMAX TILOBEMAXX¿ IMPLANT 9.0 X 9MM DZE KEYSTONE DENTAL, INC. 15712K WO-022665 D76815712K0

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention