BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, ENDOSSEOUS, ORTHODONTIC

    MDR report key: 4251431 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14747
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    March 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    OAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN DATE IN 2014. THIS REPORT IS FOR TWO UNKNOWN ORTHODONTIC BONE ANCHOR SYSTEMS/UNKNOWN LOTS. IMPLANT/EXPLANT DATE: UNKNOWN. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD FOUR BONE ANCHORS REMOVED. TWO OF THE BONE ANCHORS WERE NON-SYNTHES BONE ANCHORS. THE NON-SYNTHES BONE ANCHORS WERE REMOVED EASILY. THE TWO SYNTHES BONE ANCHORS WERE COVERED BY BONE GROWTH. THE SURGEON HAD TO TAKE A DRILL TO REMOVE THE GROWTH; THE SLOT WAS DAMAGED AND THEY COULD NOT TAKE THE SCREW OUT. THE BONE ANCHORS WERE TAKEN OUT IN MANY PIECES AND THEY HAD TO GIVE UP TAKING THE SYNTHES SCREWS OUT. THERE WAS A THIRTY MINUTES DELAY IN THE PROCEDURE. THIS REPORT IS FOR TWO UNKNOWN ORTHODONTIC BONE ANCHOR SYSTEMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736511 IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR