BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HOFFMANN II EXTERNAL FIXATOR

    MDR report key: 15275909 · Received August 23, 2022

    Report

    Report Number
    0008031020-2022-00409
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 3, 2019
    Report Date
    August 23, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW PUBLISHED BY THE ¿DEPARTMENT OF EMERGENCY, TRAUMA CENTER, CHANGHAI HOSPITAL, THE SECOND MILITARY MEDICAL UNIVERSITY, CHINA¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-019-2679-9. THE REPORTED EVENT OF MAL-REDUCTION/LOSS OF REDUCTION 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'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE.   IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF EMERGENCY, TRAUMA CENTER, CHANGHAI HOSPITAL, THE SECOND MILITARY MEDICAL UNIVERSITY, CHINA¿. THE TITLE OF THIS REPORT IS ¿TREATMENT OF OPEN TIBIAL DIAPHYSEAL FRACTURES BY EXTERNAL FIXATION COMBINED WITH LIMITED INTERNAL FIXATION VERSUS SIMPLE EXTERNAL FIXATION: A RETROSPECTIVE COHORT STUDY¿, PUBLISHED ON JULY 03, 2019, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.1186/S12891-019-2679-9. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿HOFFMANN II EXTERNAL FIXATION SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 152 PATIENTS. THE CASES IN THIS STUDY RANGE FROM JANUARY 2012 AND DECEMBER 2016. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 26 PATIENTS EXPERIENCED MALREDUCTION OR LOSS OF REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635367 UNKNOWN HOFFMANN II EXTERNAL FIXATOR APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other