BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRANEMARK SA TAPERED SLOT SCREW

    MDR report key: 1871777 · Received October 16, 2010

    Report

    Report Number
    2917088-2010-00014
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ATTACHMENTS INTL., INC.
    Product Code
    DZE
    PMA / PMN Number
    K904236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT TWO BRANEMARK SA TAPERED SLOT SCREWS HAD FRACTURED. THE FRACTURES WERE DISCOVERED WHEN THE PATIENT'S PARTIAL BECAME LOOSE. THE DOCTOR WAS UNABLE TO RETRIEVE THE BROKEN SCREWS AT THE TIME OF THE PATIENT'S VISIT, THEREFORE THE PATIENT IS SCHEDULED TO RETURN TO THE DOCTOR'S OFFICE TO HAVE THE REMAINING PORTION OF THE FRACTURED SCREWS REMOVED, WHICH THE DOCTOR INTENDS TO RETURN TO ATTACHMENTS INTERNATIONAL FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE SCREWS MET PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT A BRANEMARK SA TAPERED SLOT SCREW HAD FRACTURED. THIS IS THE SECOND OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRANEMARK SA TAPERED SLOT SCREW ENDOSSEOUS DENTAL IMPLANT DZE ATTACHMENTS INTL., INC. 042406-15B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other