BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES

    MDR report key: 4559420 · Received March 2, 2015

    Report

    Report Number
    2520274-2015-11357
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE REPORTED AS: (B)(6) 2015. 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 THE BRACKET PART BROKE OFF WHEN TENSION ON WIRE WAS APPLIED. HEAD WAS LOST (SUCKED UP IN VACUUM SYSTEM). THE SURGERY WAS NOT PROLONGED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142311 TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1