BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM

    MDR report key: 4811551 · Received June 2, 2015

    Report

    Report Number
    2520274-2015-14172
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 11, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. EVENT DATE: UNKNOWN. DEVICE IS PLANNED TO BE EXPLANTED ON (B)(6) 2015, BUT HAS NOT BEEN EXPLANTED YET. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER, 04.500.026.01, 1.55MM MIDFACE SELF-DRILLING SCREW, LOT NUMBER UNKNOWN). THE SUBJECT DEVICE WAS RETURNED IN GOOD CONDITION WITH NO FUNCTIONAL DAMAGE AND ONLY MINOR MARRING AROUND THE HEX DRIVE. DUE TO THE NATURE OF THE COMPLAINT, THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED OR VERIFIED. THE CAUSE OF THE COMPLAINT CONDITION COULD NOT BE DETERMINED. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS UNCONFIRMED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE 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

    IT WAS REPORTED THAT WHEN THE PATIENT CAME IN FOR FOLLOW UP, THE SURGEON NOTED ORTHODONTIC BONE ANCHOR (OBA) PLATE AND SCREW CONSTRUCT IS LOOSE. SURGEON IS PLANNING TO REMOVE IMPLANTS ON (B)(6) 2015 AND REPLACE WITH NEW IMPLANTS. THIS IS REPORT 15 OF 16 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH ORTHODENTIC BONE ANCHORS (OBA). DURING A FOLLOW UP VISIT, THE SURGEON NOTICED THAT TWO (2) OBA PLATES IN MAXILLA WERE BECOMING LOOSE. THE SURGEON BROUGHT THE PATIENT BACK TO HIS OFFICE WHERE HE REMOVED THE HARDWARE IN MAXILLA (TWO PLATES AND SIX SCREWS) AND REPLACED IT WITH NEW OBA PLATES AND SCREWS. THE REVISION PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2015 WITH NO SURGICAL DELAY NOTED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354387 TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention