BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 874320 · Received June 28, 2007

    Report

    Report Number
    3005503242-2007-00043
    Event Type
    Other
    Date Received
    June 28, 2007
    Date of Event
    November 30, 2006
    Report Date
    May 14, 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

    SUMMARY MEMO ON EVALUATION: 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 HTE RETURNED PRODUCT'S DIMENSIONS TO VERIFY IF THE PRODUCT MEETS ITS SPECIFICATIONS. RESULTS: SEE ATTACHED TEST DATA. AS A RESULT OF A SEM IMAGING, SLA TYPE SURFACE TREATMENT WAS COPLETED. 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, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR. SEE ADDITIONAL PAGES.

    Description of Event or Problem · 1

    PRODUCTS WERE RETURNED AS IMPLANT FAILURE. REPORT STATED THAT THE PT HAS AN INSUFFICIENT BONE QUALITY; HOWEVER, IT ALSO STATED THAT THE REASON FOR IMPLANT FAILURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE BIOMEDICARE, INC. FX4308 05I26-A

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention