BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 2032657 · Received March 15, 2011

    Report

    Report Number
    3005503242-2011-00011
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 28, 2011
    Manufacturer
    DENTIUM USA
    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

    CONCLUSION: BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPEC. THE IMPLANT WAS EXPLANTED DUE TO PAIN AND DISCOMFORT TO THE PT. 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.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE THE PT FELT PAIN AND DISCOMFORT SO THE DOCTOR REMOVED THE IMPLANT. BASED ON THE REPORT, THE PT HAD MODERATE ORAL HYGIENE AND GOOD BONE CONDITION. THE SURGERY WAS A TRADITIONAL 2 STAGE WITH A SINGLE PROSTHETIC ATTACHMENT IN TOOTH LOCATION #30. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PT OUTCOME WAS REPORTED AS RECOVERED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERLINE ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX5012SW F27ZA016S

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention