BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 7845771 · Received September 5, 2018

    Report

    Report Number
    2939274-2018-53607
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 9, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GXR
    UDI-DI
    10887587018324
    PMA / PMN Number
    K123723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: JEY, GWO. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS ARE ADDRESSED IN (B)(4). THIS REPORT WILL ADDRESS THE REMAINING DEVICES. THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687683 TI MATRIXNEURO SCREW SELF-DRILLING 4MM COVER, BURR HOLE GXR WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.503.104.01 10887587018324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention