BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM

    MDR report key: 6004291 · Received October 6, 2016

    Report

    Report Number
    2520274-2016-14818
    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. PATIENT WEIGHT IS UNKNOWN. 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 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659933 TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention