BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMA IMPLANT

    MDR report key: 9535389 · Received December 31, 2019

    Report

    Report Number
    1020279-2019-04715
    Event Type
    Injury
    Date Received
    December 31, 2019
    Report Date
    June 16, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IN A SCIENTIFIC PUBLICATION, CETIN 2019, "EVALUATION OF CLINICAL RESULTS OF PROXIMAL FEMORAL NAILS IN INTERTROCHANTERIC FRACTURE TREATMENT EVALUATION" IT WAS REPORTED THAT A PATIENT PRESENTED A FISSURE ON THE NAIL DISTAL SCREW AND THIS WAS TREATED WITH A PLAQUE AND CABLES, LEAVING THE NAIL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331004 TRAUMA IMPLANT NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R