BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 851280 · Received May 3, 2007

    Report

    Report Number
    3005503242-2007-00031
    Event Type
    Other
    Date Received
    May 3, 2007
    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: IN 20YPE 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: WE COULD CONCLUDE THAT THE IMPLANT FAILURE WAS NOT DUE TO THE DEFICIENCIES OF THE PRODUCT. POSSIBLE CAUSE MAY BE SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PATIENT BEHAVIOR, ETC. SEE ADD'L PAGES.

    Description of Event or Problem · 1

    REPORT STATED, THAT IMPLANTS FAILED DUE TO THE FIXTURE'S INITIAL INSTABILITY. ON INVESTIGATION, DENTIST WAS UNABLE TO RECALL SPECIFIC PATIENT(S) AND COULD NOT PROVIDE ANY ADD'L INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE BIOMEDICARE, INC. FX3810 05K08-C

    Patients

    Seq Age Sex Outcome Treatment
    1 YR