BEUDAMED
    FDA Adverse Event Other Summary report: N

    SM IMPLANT SYSTEM

    MDR report key: 3144981 · Received May 28, 2013

    Report

    Report Number
    3006113174-2013-00001
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 27, 2013
    Manufacturer
    DIO CORP.
    Product Code
    DZE
    PMA / PMN Number
    K080559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND WITHIN SPECIFICATION. ALTHOUGH RARELY, TITANIUM ALLERGY IS A KNOWN CONTRAINDICATION FOR DENTAL IMPLANTS. THE PATIENT WOULD NEED TO BE TESTED BY ALLERGIST TO DETERMINE WHETHER THE PATIENT HAS A METAL ALLERGY OR NOT. THE DENTIST REMOVED THE IMPLANT AS A PRECAUTION SINCE THE PATIENT WAS COMPLAINING OF DULL PAIN.

    Description of Event or Problem · 1

    A PATIENT HAD DULL PAIN ON THE AREA ON IMPLANT PLACED, #25. THE DENTIST REMOVED THE IMPLANT AS A PRECAUTION IN CASE THE PATIENT HAD AN UNDIAGNOSED METAL ALLERGY. PATIENT WAS REFERRED TO AN ALLERGIST FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232747 SM IMPLANT SYSTEM DZE DIO CORP. SFR 4510 KR120110P11

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other