BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XP1 SINGLE SYSTEM DENTAL IMPLANT

    MDR report key: 1080959 · Received July 23, 2008

    Report

    Report Number
    3005990499-2008-00019
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K071070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES, UNCONTROLLED HYPERTENSION, ETC. PT 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. THE DEVICE HISTORY RECORD FOR THIS LOT OF IMPLANTS WAS REVIEWED AND PROCESS AND STERILIZATION PARAMETERS WERE FOUND TO BE AS SPECIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED AGAINST LOT 57935407 FOR CATALOG # A10304. IN CONCLUSION, THE LACK OF OSSEOINTEGRATION IS A WELL-DOCUMENTED AND INHERENT RISK OF DENTAL IMPLANTS.

    Description of Event or Problem · 1

    THIS COMPLAINT INVOLVES A REPORT OF AN IMPLANT THAT FAILED TO OSSEOINTEGRATE. IN 2008, A MALE UNDERWENT A SUCCESSFUL PROCEDURE WITH IMPLANTATION OF AN XP1 SINGLE SYSTEM DENTAL IMPLANT AT SITE#:7. PRIMARY STABILITY RATING WAS NOTED AS 'GOOD'. ON FIVE MONTHS LATER, THE IMPLANT AT #19 WAS NOTED TO HAVE FAILED TO OSSEOINTEGRATE AND WAS LOOSE. THE IMPLANT HAD BEEN TEMPORIZED. ON THREE DAYS LATER, THE IMPLANT WAS REMOVED. THE SITE WAS AUGMENTED WITH IMMEDIATE IMPLANTATION OF ANOTHER XP1 IMPLANT. THE PT WAS REPORTED TO HAVE HYPERTENSION AND BPH (BENIGN PROSTATE HYPERTROPHY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XP1 SINGLE SYSTEM DENTAL IMPLANT DZE KEYSTONE DENTAL NA 57935407

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention