BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM

    MDR report key: 6004296 · Received October 6, 2016

    Report

    Report Number
    2520274-2016-14806
    Event Type
    Injury
    Date Received
    October 6, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K050608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: DZL. (B)(4). 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. 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 A PATIENT UNDERWENT A CRANIOPLASTY PROCEDURE ON (B)(6) 2016, AND WAS IMPLANTED WITH CRANIOS FAST SET PUTTY, STERILE, 0.4MM TITANIUM MATRIXNEURO RECONSTRUCTION MESH, AND EIGHT (8) TITANIUM MATRIXMIDFACE SCREWS, SELF-DRILLING. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO REMOVE THE MESH DUE TO AN INFECTION, SPECIFICALLY A HOLE IN THE SKIN WHERE THE CRANIOS PUTTY WAS IMPLANTED. DEBRIDEMENT WAS REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 4 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659934 TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention