BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM

    MDR report key: 4180622 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14155
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    PK963546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ON AN UNKNOWN DATE THE PATIENT WAS IN AN ALTERCATION AND HIS MANDIBLE WAS FRACTURED. HIS WAS PLATED WITH A MANDIBLE LOCKING PLATE (MLP) CURVED SHUT PLATE AND 8 SCREWS. ON (B)(6) 2014, THE PATIENT WAS SENT TO SURGERY TO REMOVE ALL THE HARDWARE DUE TO INFECTION. IT WAS NOTICED DURING SURGERY THAT THE THIRD MOLAR WAS EXPOSED AND INFECTED. IT IS UNKNOWN IF THE INFECTION WAS DUE TO THE TOOTH INFECTION OR THE PLATE. DURING THE REMOVAL, IT WAS NOTED THE INFECTION SPREAD THROUGH THE MANDIBLE BONE. THE BONE HEALED AS EXPECTED AND ALL LOCKING SCREWS WERE INTACT UPON REMOVAL. THE PATIENT WAS TREATED WITH ANTIBIOTICS POST-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT NUMBER 9 OF 9 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663213 2.0MM TI CORTEX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 5MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention