BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STANDARD GAMMA NAIL (SGN) CASE 2 REVISED

    MDR report key: 6123268 · Received November 22, 2016

    Report

    Report Number
    0009610622-2016-00540
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    December 14, 2015
    Report Date
    October 27, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THIS PRODUCT INQUIRY ADDRESSES 5 POSTOPERATIVE INTRA-ARTICULAR LAG SCREW PROTRUSIONS IN CONJUNCTION TO THE SGN SYSTEM (1 EVENT), TGN SYSTEM (1 EVENT) AND GAMMA3 SYSTEM (3 EVENTS). REVISION WITH A SMALLER SCREW (3X SGN). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAD NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 11 COMPLAINTS WERE INITIATED RETROSPECTIVELY. THE MANUFACTURER BECAME AWARE BY AN ITALIAN PUBLICATION "HOW EVOLUTION OF THE NAILING SYSTEM IMPROVES RESULTS AND REDUCES ORTHOPEDIC COMPLICATIONS: MORE THAN 2000 CASES OF TROCHANTERIC FRACTURES TREATED WITH THE GAMMA NAIL SYSTEM¿, PUBLISHED ON 14TH DECEMBER 2015 REGARDING THE GAMMA SYSTEM (SGN, TGN, GAMMA3 ¿ ALL TROCHANTERIC NAILS) THAT IN SUM 63 PATIENTS HAD BEEN OBSERVED PRESENTING 11 ADVERSE EVENTS IN A PERIOD FROM JANUARY 1997 TO DECEMBER 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770935 UNKNOWN STANDARD GAMMA NAIL (SGN) CASE 2 REVISED IMPLANT HSB STRYKER TRAUMA KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention