BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GAMMA 3 NAIL

    MDR report key: 14828478 · Received June 27, 2022

    Report

    Report Number
    0009610622-2022-00303
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    October 1, 2014
    Report Date
    June 27, 2022
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF EVENTS SUMMARIZED AS PART OF LITERATURE REVIEW WHEN DEVICE AND PATIENT INFORMATION IS NOT AVAILABLE. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF IMPLANT LOOSENING COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPEDICS, ORTHOPEADIC HOSPITAL, JILIN UNIVERSITY SCHOOL OF SECOND HOSPITAL, CHINA¿. THE TITLE OF THIS REPORT IS, ¿INTERTAN NAIL VERSUS GAMMA3 NAIL FOR INTRAMEDULLARY NAILING OF UNSTABLE TROCHANTERIC FRACTURES¿, PUBLISHED ON OCTOBER 1, 2014, WHICH IS ASSOCIATED WITH THE STRYKER ¿GAMMA-3 NAILING SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTP://DX.DOI.ORG/ 10.1186/S13000-014-0191-Y. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 261 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM JANUARY 2008 TO MAY 2013. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 2 PATIENTS EXPERIENCED IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071264 UNKNOWN GAMMA 3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other