BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XP1 SINGLE SYSTEM DENTAL IMPLANT

    MDR report key: 1143684 · Received August 29, 2008

    Report

    Report Number
    3005990499-2008-00021
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K071070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS. (1,2,3,4,5). IN ADDITION, FAILURE TO OSSEOINTEGRATE IS INCLUDED IN THE XP1 SYSTEM LABELING AS A KNOWN COMPLICATION. THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. (5) THESE INCLUDE PATIENT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES, SYSTEMIC CONDITIONS SUCH AS DIABETES, UNCONTROLLED HYPERTENSION, ETC. PATIENT HABITS SUCH AS TOBACCO USE, ALCOHOL OR DRUG ABUSE, POOR ORAL HYGIENE, AND BRUXISM MAY ALSO LEAD TO IMPLANT FAILURE. IN ADDITION, IMPROPER SURGICAL TECHNIQUE CAN LEAD TO IMPLANT FAILURE AND/OR LOSS OF SUPPORTING BONE. EVALUATION OF THE RETURNED DEVICE WAS PERFORMED. NO ANOMALIES WERE IDENTIFIED. IN CONCLUSION, THE LACK OF OSSEOINTEGRATION OF THIS DENTAL IMPLANT IS DUE TO PATIENT FACTORS, AND IS A WELL-DOCUMENTED AND INHERENT RISK OF DENTAL IMPLANTS.

    Description of Event or Problem · 1

    IN 2008, A MALE UNDERWENT SUCCESSFUL IMPLANTATION OF THE XP1 SINGLE SYSTEM DENTAL IMPLANT IN TYPE I BONE AT SITE #19. PRIMARY STABILITY RATING WAS NOTED AS "GOOD". PATIENT IS A SMOKER. FIVE MONTHS LATER, THE ABUTMENT WAS PLACED. NO ISSUES WERE NOTED. THE FOLLOWING MONTH, UPON REMOVAL OF THE HEALING CAP DURING RESTORATION, THE IMPLANT WAS NOTED TO BE "SIGNIFICANTLY LOOSENED". ONE WEEK LATE,, THE IMPLANT WAS REMOVED; SITE WAS GRAFTED AND IMMEDIATE IMPLANTATION OF ANOTHER IMPLANT (TYPE NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XP1 SINGLE SYSTEM DENTAL IMPLANT DZE KEYSTONE DENTAL NA 58701608

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention