BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMA

    MDR report key: 19546922 · Received June 17, 2024

    Report

    Report Number
    3005990499-2024-71099
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    March 9, 2024
    Report Date
    June 17, 2024
    Manufacturer
    KEYSTONE DENTAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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).

    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). UPDATING REPORT TO REFLECT THE CORRECT FDA SUBMISSION DATE.

    Description of Event or Problem · 0

    FAILED TO OSSEOINTEGRATE.

    Description of Event or Problem · 0

    FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652257 PRIMA PRIMACONNEX STRAIGHT WD 5.0X10 DZE KEYSTONE DENTAL, INC. 15435K UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention