BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 847055 · Received May 3, 2007

    Report

    Report Number
    3005503242-2007-00013
    Event Type
    Other
    Date Received
    May 3, 2007
    Date of Event
    August 17, 2006
    Report Date
    October 13, 2006
    Manufacturer
    BIOMEDICARE, INC.
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS NOT INITIALLY INVESTIGATED. COMPLAINT PROCEDURE RECENTLY REVISED TO REQUIRE APPROPRIATE INVESTIGATION & REPORTING OF EVENTS. REPORT BEING SUBMITTED SUBSEQUENT TO COMPLETION OF INVESTIGATION. DATE OF TEST: 2007. TYPE OF TEST(S): SEND THE RETURNED PRODUCT TO THE LAB FOR SEM (SCANNING ELECTRON MICROSCOPE) IMAGING TO VERIFY SLA (SAND BLASTING WITH LARGE GRIT AND ACID ETCHING) TYPE SURFACE TREATMENT WAS COMPLETED. RE-INSPECT THE RETURNED PRODUCT'S DIMENSIONS TO VERIFY IF THE PRODUCT MEETS ITS SPECIFICATIONS. RESULTS: AS A RESULT OF A SEM IMAGING, SLA TYPE SURFACE TREATMENT WAS COMPLETED. AS A RESULT OF A RE-INSPECTION, THE PRODUCT MEETS ITS SPECIFICATIONS. CONCLUSION: BASED ON INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.

    Description of Event or Problem · 1

    INITIAL REPORT STATED THAT OSSEOINTEGRATION DID NOT OCCUR. ON INVESTIGATION, DENTIST SUBSEQUENTLY STATED THAT THE PATIENT BONE CONDITION IS THE CAUSE OF THE IMPLANT FAILURE AND REQUIRED EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE BIOMEDICARE, INC. FX3810 05K04-C

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention UNKNOWN.