BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XP1 SINGLE SYSTEM DENTAL IMPLANT

    MDR report key: 1080960 · Received July 23, 2008

    Report

    Report Number
    3005990499-2008-00018
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 2, 2008
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K071070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. (1) 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 SIMILAR COMPLAINTS REPORTED FROM THIS LOT. THE DEVICE WAS NOT RETURNED FOR EVAL. IN CONCLUSION, FAILURE OF A DENTAL IMPLANT IS A WELL-DOCUMENTED AND INHERENT RISK OF DENTAL IMPLANTS. BASED ON INFO PROVIDED, THE ROOT CAUSE OF THIS IMPLANT FAILURE IS DUE TO RESTORATIVE CLINICIAN ERROR WHEN PLACING THE CROWN. LANG NP, ET AL, CONSENSUS STATEMENT AND RECOMMENDED CLINICAL PROCEDURES REGARDING IMPLANT SURVIVAL AND COMPLICATIONS, JOMI, SUPPLEMENT 2004.

    Description of Event or Problem · 1

    IN EARLY 2008, A FEMALE UNDERWENT A SUCCESSFUL PROCEDURE WITH IMPLANTATION OF AN XP1 SINGLE SYSTEM DENTAL IMPLANT. PRIMARY STABILITY RATING WAS NOTED AS 'SATISFACTORY'. ON APPROX THREE MONTHS LATER, THE PT REPORTED THAT IMMEDIATE PAIN UPON SEATING OF THE CROWN BY THE GENERAL DENTIST. A 1-2 MM HYPER-OCCLUSION WAS NOTED. OCCLUSAL ADJUSTMENT PERFORMED. ON THREE MONTHS LATER, THE CROWN MARGINS WERE NOTED TO BE OPEN ON BUCCAL AND LINGUAL. IMPLANT REMOVED. SITE WAS AUGMENTED. THE CLINICIAN HAS REPORTED THAT THE IMPLANT FAILURE IS NOT RELATED TO THE XP1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XP1 SINGLE SYSTEM DENTAL IMPLANT DZE KEYSTONE DENTAL NA 57835407

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention