BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN APEX PINS

    MDR report key: 14863777 · Received June 29, 2022

    Report

    Report Number
    0008031020-2022-00311
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    October 13, 2016
    Report Date
    August 19, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF INFECTION AND RADIAL NERVE INJURY 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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO SUSPECTED MEDICAL DEVICE IN SECTION D. THIS INCLUDES THE FOLLOWING; PRODUCT LONG DESCRIPTION, PRODUCT CODE, AND COMMON DEVICE NAME. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF INFECTION AND RADIAL NERVE INJURY COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS 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 ¿HOSPITAL 12 DE OCTUBRE, ORTHOPAEDIC AND TRAUMA SURGERY SECRETARIAT, SPAIN¿. THE TITLE OF THIS REPORT IS, ¿ANALYSIS OF COMPLICATIONS AFTER A FLOATING ELBOW INJURY¿, PUBLISHED ON OCTOBER 13, 2016, WHICH IS ASSOCIATED WITH THE STRYKER ¿HOFFMANN II EXTERNAL FIXATION SYSTEM¿. THE ARTICLE CAN BE FOUND AT DOI 10.1007/S00590-016-1866-8. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 23 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM 2004 TO 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 1 PATIENT EXPERIENCED INFECTION AND RADIAL NERVE INJURY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿HOSPITAL 12 DE OCTUBRE, ORTHOPAEDIC AND TRAUMA SURGERY SECRETARIAT, SPAIN¿. THE TITLE OF THIS REPORT IS, ¿ANALYSIS OF COMPLICATIONS AFTER A FLOATING ELBOW INJURY¿, PUBLISHED ON OCTOBER 13, 2016, WHICH IS ASSOCIATED WITH THE STRYKER ¿HOFFMANN II EXTERNAL FIXATION SYSTEM¿. THE ARTICLE CAN BE FOUND AT DOI 10.1007/S00590-016-1866-8. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 23 PATIENTS, AND THE CASES IN THIS STUDY RANGE FROM 2004 TO 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 1 PATIENT EXPERIENCED INFECTION AND RADIAL NERVE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817589 UNKNOWN APEX PINS PIN, FIXATION, THREADED JDW STRYKER GMBH UNKNOWN
    2892692 UNKNOWN APEX PINS PIN, FIXATION, THREADED JDW STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other