BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L

    MDR report key: 16364371 · Received February 13, 2023

    Report

    Report Number
    8030965-2023-01753
    Event Type
    Injury
    Date Received
    February 13, 2023
    Report Date
    February 13, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07612334089977
    PMA / PMN Number
    K172872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. DEVICE HISTORY LOT: PART# 04.168.495S. LOT # L963844. MANUFACTURING SITE: WERK GRENCHEN. SUPPLIER: NA. RELEASE TO WAREHOUSE DATE: 27 JUN 2018. EXPIRATION DATE: NA.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE FNS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, NON-UNION WAS CONFIRMED, AND IT WAS ON THE VERGE OF CUT-OUT. ON (B)(6) 2023, THE FNS WILL BE REMOVED, AND BHA WILL BE PERFORMED. ACCORDING TO THE SURGEON, IN THE PRIMARY SURGERY, THE INLAYING CONDITION WAS REDUCED AND FIXED. FULL LOAD WAS APPLIED IMMEDIATELY AFTER SURGERY. AS A RESULT, THE SURGEON GUESSED THAT RE-INLAYING AND NON-UNION OCCURRED. THIS REPORT IS FOR ONE (1) ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388135 ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH L963844 07612334089977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ANTIROTSCR F/FEM NECK SYST F/CONSTRUCT L.| LOCKSCR Ø5 SELF-TAP L44 TAN.| PL 1-HO F/FEM NECK SYST TAN.