BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: CORTEX

    MDR report key: 20193107 · Received September 11, 2024

    Report

    Report Number
    8030965-2024-11255
    Event Type
    Injury
    Date Received
    September 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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

    THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN (B)(6)2000 TO (B)(6)2023 AT UNIVERSITY OF UTAH. REASON FOR IMPLANTATION FRACTURE FIXATION. POST OP COMPLICATION INCLUDED PATIENT IS HAVING PAIN FROM HARDWARE IN THE THIGH AND HIP WHICH MAKES EXERCISE AND ACTIVITY DIFFICULT. SCREW PROMINENCE. TREATMENT/INTERVENTION INCLUDED WAS HWR - REMOVAL OF BLADE PLATE AND SCREWS IMPLANT(S) INVOLVED: 95 DEGREE 80MM X 1. CORTEX SCREW X 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474017 UNK - SCREWS: CORTEX SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention