BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI OBA SCREW ANCHOR 10MM SELF-DRILLING-STERILE

    MDR report key: 4615959 · Received March 19, 2015

    Report

    Report Number
    2520274-2015-11920
    Event Type
    Injury
    Date Received
    March 19, 2015
    Report Date
    March 2, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT WAS PROVIDED. 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 AN ORTHODONTIC BONE ANCHOR SCREW BECAME LOOSE AFTER SEVERAL WEEKS OF USE. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2014 WHEN TWO (2) SCREWS WERE PLACED IN THE MANDIBLE. ONLY ONE (1) OF THOSE SCREWS HAS COME LOOSE. THE COMPLAINANT SCREW WAS REMOVED. THE SURGEON WANTS TO REPLACE IT WITH ANOTHER SCREW SO THAT THE TEETH CONTINUE TO PROGRESS FURTHER ALONG WITH THE USE OF THE MANDIBLE. IT WAS ALSO REPORTED THAT RIGHT THE BONE ANCHOR SCREW BECAME LOOSE BECAUSE IT WAS NOT SCREWED IN PROPERLY. ON (B)(6) 2015 THE SCREW WAS EXPLANTED AND A COMPETITOR'S 9MM SCREW WAS PLACED, ON (B)(6) 2015 THE SURGEON TOOK THE COMPETITORS SCREW OUT AND TRIED TO PLACE A SCREW ANCHOR 10MM SELF DRILLING SCREW BUT IT NOT FIT PROPERLY AND THAN IMPLANTED A 12 MM INTRAMEDULLAR FIXATION SCREW WHICH WORKED . THERE WERE NO REPORTS OF ANY SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186496 TI OBA SCREW ANCHOR 10MM SELF-DRILLING-STERILE IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention