BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMOOTH STAPLE SCREW 1.6

    MDR report key: 1201183 · Received October 20, 2008

    Report

    Report Number
    2917088-2008-00001
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ATTACHMENTS INTL., INC.
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES AS A RESULT OF THE REPORTED INCIDENT. ACCORDING TO THE DOCTOR, SINCE THE IMPLANTATION OF THE SMOOTH STAPLE IMPLANT SYSTEM THE PATIENT FOLLOWS A PERIODIC CHECK-UP SCHEDULE. IT IS NOT UNCOMMON FOR THIS PATIENT TO COME INTO THE CHECK-UP WITH BROKEN SMOOTH STAPLE SCREWS. THE BROKEN SCREWS INVOLVED IN THIS INCIDENT WERE RETURNED TO ATTACHMENTS INTL. FOR EVALUATION. THE EVALUATION INDICATED THAT ALL FOUR SCREWS FRACTURED UNDERNEATH THE HEADS OF THE SCREWS CAUSING THE TOP PLATE TO COMPLETELY DISLODGE AND WITH IT THE PATIENT'S RESTORATION(S). IT IS BELIEVED THAT THE CAUSE OF THE SCREW FRACTURES IS MOST LIKELY DUE TO UNEVEN OR INCOMPLETE TORQUE. WITH FOUR SCREWS IN ONE IMPLANT CASE, ALL SCREWS SHOULD BE COMPLETELY TORQUED TO THE SAME SPECIFIED TORQUE. THE BROKEN SCREWS WERE REPLACED AND THE PATIENT IS DOING FINE. ALTHOUGH THERE WAS NO INJURY, THIS INCIDENT IS BEING REPORTED SINCE THIS TYPE OF MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NO OTHER INCIDENTS OF THIS NATURE HAVE BEEN REPORTED FOR THE PRODUCT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A DOCTOR REPORTED TO ATTACHMENTS INTL., INC. THAT IN 2008, ALL FOUR 1.6 SMOOTH STAPLE SCREWS BEING USED AS PART OF A PATIENT¿S TRADITIONAL SMOOTH STAPLE IMPLANT SYSTEM BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMOOTH STAPLE SCREW 1.6 ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP ATTACHMENTS INTL., INC. 03200613A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other