BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE

    MDR report key: 15240622 · Received August 17, 2022

    Report

    Report Number
    3010667733-2022-00272
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    July 21, 2022
    Report Date
    October 12, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DELAYED UNION COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. 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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO PRODUCT CODE AND COMMON DEVICE NAME.

    Description of Event or Problem · 0

    THE POST MARKET CLINICAL TEAM HAS CONDUCTED A FOLLOW-UP REPORT ON ¿A RETROSPECTIVE DATA COLLECTION OF FRACTURE FIXATION, REVISION PROCEDURES, JOINT FUSION, AND BONE RECONSTRUCTION IN THE FOOT AND TOES WITH THE ORTHOLOC 3DI HALLUX PLATING SYSTEM¿. THE STUDY WAS CONDUCTED AT 'COOPER UNIVERSITY HOSPITAL, COOPER BONE AND JOINT INSTITUTE, USA'. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿ORTHOLOC 3DI HALLUX PLATING SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 46 PATIENTS. THE CASES IN THE STUDY RANGE FROM JANUARY 1, 2010, TO AUGUST 31, 2021. THE REPORT INDICATES THAT 3 PATIENTS EXPERIENCED DELAYED UNION.

    Description of Event or Problem · 0

    THE POST MARKET CLINICAL TEAM HAS CONDUCTED A FOLLOW-UP REPORT ON ¿A RETROSPECTIVE DATA COLLECTION OF FRACTURE FIXATION, REVISION PROCEDURES, JOINT FUSION, AND BONE RECONSTRUCTION IN THE FOOT AND TOES WITH THE ORTHOLOC 3DI HALLUX PLATING SYSTEM¿. THE STUDY WAS CONDUCTED AT 'COOPER UNIVERSITY HOSPITAL, COOPER BONE AND JOINT INSTITUTE, USA'. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿ORTHOLOC 3DI HALLUX PLATING SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 46 PATIENTS. THE CASES IN THE STUDY RANGE FROM JANUARY 1, 2010, TO AUGUST 31, 2021. THE REPORT INDICATES THAT 3 PATIENTS EXPERIENCED DELAYED UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239200 UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE PLATE, FIXATION, BONE HRS WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN
    2946111 UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE PLATE, FIXATION, BONE HRS WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other