BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM

    MDR report key: 17416126 · Received July 28, 2023

    Report

    Report Number
    8030965-2023-09517
    Event Type
    Injury
    Date Received
    July 28, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10: THERAPY DATE IS IN JANUARY 2023. H3, H4, H6: PRODUCT CODE: 413.342S LOT NUMBER : L963755 RELEASE TO WAREHOUSE DATE : 29.JUNE.2018 EXPIRATION DATE : NA SUPPLIER: NA MANUFACTURING SITE: WERK GRENCHEN A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCE'S WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY TO IMPLANT THE PLATE AND SCREWS IN JANUARY OF 2021. ON AN UNKNOWN DATE, THE DEVICES WERE EXPLANTED DUE TO INFECTION. THIS REPORT IS FOR A 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325918 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH L963755

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention CORTSCR Ø4.5 SELF-TAP L42 TI| CORTSCR Ø4.5 SELF-TAP L42 TI| CORTSCR Ø4.5 SELF-TAP L44 TI| CORTSCR Ø4.5 SELF-TAP L44 TI| CORTSCR Ø4.5 SELF-TAP L44 TI| DHS/DCS-COMPRSCR L36 TAN| DHS/DCS-SCR L95 TAN| LCP DHS-PL 135° 6HO L124 STANDBARREL TAN