BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XP1 SINGLE SYSTEM DENTAL IMPLANT

    MDR report key: 1143685 · Received August 29, 2008

    Report

    Report Number
    3005990499-2008-00020
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 8, 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, 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. THE DEVICE HISTORY RECORD FOR THIS LOT OF IMPLANTS WAS REVIEWED AND PROCESS AND STERILIZATION PARAMETERS WERE FOUND TO BE AS SPECIFIED. IN CONCLUSION, THE LACK OF OSSEOINTEGRATION IS A WELL-DOCUMENTED AND INHERENT RISK OF DENTAL IMPLANTS. REFERENCES: DEGIDI M. ET AL, CLINICAL OUTCOME OF 802 IMMEDIATELY LOADED 2-STAGE SUBMERGED IMPLANTS WITH A NEW GRIT-BLASTED AND ACID ETCHED SURFACE: 12 MONTH FOLLOW UP. INT J ORAL MAXILLOFAC IMPLANTS. IN 2006; 21(5): 763-8. LINDEBOOM JA, ET AL, IMMEDIATE PLACEMENT OF IMPLANTS IN PERIAPICAL INFECTED SITES: A PROSPECTIVE RANDOMIZED STUDY IN 50 PATIENTS. ORAL SURG ORAL MED OR PATHOL ORAL RADIOL ENDOD. IN 2006; 101(6):705-10. EPUB 2006. GOENE R ET AL, PERFORMANCE OF SHORT IMPLANTS IN PARTIAL RESTORATIONS: 3 YEAR FOLLOW-UP OF OSSEOTITE IMPLANTS. IMPLANT DENT, 2005; 14(3):274-80. GALUSER R ET AL., IMMEDIATE OCCLUSAL LOADING OF BRANEMARK SYSTEM TIUNITE IMPLANTS PLACE PREDOMINATELY IN SOFT BONE: 4 YEAR RESULTS OF A PROSPECTIVE CLINICAL STUDY, CLIN IMPLANT DENT RELAT RES, 2005;7 SUPPL 1:S52-9. LANG NP, ET AL, CONSENSUS STATEMENT AND RECOMMENDED CLINICAL PROCEDURES REGARDING IMPLANT SURVIVAL AND COMPLICATIONS, JOMI, SUPPLEMENT 2004. KEYSTONE DENTAL.

    Description of Event or Problem · 1

    THIS COMPLAINT INVOLVES A REPORT OF AN IMPANT THAT FAILED TO OSSEOINTEGRATE. IN 2008, A MALE UNDERWENT SUCCESSFUL IMPLANTATION OF THREE XP1 SINGLE SYSTEM DENTAL IMPLANTS AT SITES 28, 29 AND 30. PRIMARY STABILITY RATING WAS "GOOD". IN 2008, THE FULLY RESTORED IMPLANT AT SITE#: 30 WAS NOTED TO HAVE FAILED TO OSSEOINTEGRATE AND WAS REMOVED. THE REMAINING TWO IMPLANTS REMAIN VIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XP1 SINGLE SYSTEM DENTAL IMPLANT DZE KEYSTONE DENTAL NA 57800808

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention