BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 3MM

    MDR report key: 13592944 · Received February 24, 2022

    Report

    Report Number
    2939274-2022-00656
    Event Type
    Injury
    Date Received
    February 24, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GWO
    UDI-DI
    10887587018294
    PMA / PMN Number
    K123723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROCODES: GXR, JEY. 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROCODES: GXR, JEY. 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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 · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672859 TI MATRIXNEURO SCREW SELF-DRILLING 3MM PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE GWO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.503.103.01 10887587018294

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention TI MATRIXNEURO BURR HOLE COVER 17MM| TI MATRIXNEURO SCREW SELF-DRILLING 3MM