BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 5MM

    MDR report key: 13551763 · Received February 17, 2022

    Report

    Report Number
    8030965-2022-00949
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    January 19, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    GWO
    UDI-DI
    07611819901667
    PMA / PMN Number
    K123723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE PRODUCT CODES: JEY; GXR. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. 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. 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 DEVICE PRODUCT CODES: JEY; GXR. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. 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. 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

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE ON (B)(6) 2022 THE TWO (2) TI MATRIXNEURO SCREWS BROKE DURING THE SKULL BONE FIXATION. THE SCREW HEADS BROKE OFF FROM THE SCREW SHAFTS AND THE TWO (2) SCREW SHAFTS ARE STILL IN THE PATIENT'S SKULL BONE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE ON (B)(6) 2022 THE TWO (2) TI MATRIXNEURO SCREWS BROKE DURING THE SKULL BONE FIXATION. THE SCREW HEADS BROKE OFF FROM THE SCREW SHAFTS AND THE TWO (2) SCREW SHAFTS ARE STILL IN THE PATIENT'S SKULL BONE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760231 TI MATRIXNEURO SCREW SELF-DRILLING 5MM PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE GWO SYNTHES GMBH 07611819901667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention