BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM

    MDR report key: 17415148 · Received July 28, 2023

    Report

    Report Number
    8030965-2023-09499
    Event Type
    Injury
    Date Received
    July 28, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDO
    PMA / PMN Number
    K953607
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10: THERAPY DATE IS IN (B)(6)2023. H3, H4, H6: PART:480.950 LOT:4L63312 MANUFACTURING SITE: WERK BALSTHAL SUPPLIER:NA RELEASE TO WAREHOUSE DATE: 13 MAY 2019 EXPIRATION DATE:NA A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES 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 (B)(6)2021. ON AN UNKNOWN DATE, THE DEVICES WERE EXPLANTED DUE TO INFECTION. THIS REPORT IS FOR A TI DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM THIS IS REPORT 2 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966786 TI DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR JDO SYNTHES GMBH

    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| LCP DHS-PL 135° 6HO L124 STANDBARREL TAN| LOCKSCR ø5 SELF-TAP L42 TAN