BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US LARGE

    MDR report key: 17760181 · Received September 15, 2023

    Report

    Report Number
    3016573902-2023-00009
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    June 13, 2023
    Report Date
    March 22, 2024
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    UDI-DI
    17290013396065
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: SWELLING PROBABLE ROOT CAUSE: APPLICATION USE OF EXPIRED PRODUCT. WRONG STORAGE CONDITIONS (HIGH TEMPERATURES OR EXPOSURE TO HUMIDITY <40%). RE-USE OF SINGLE-USE DEVICE. USE OF CONTRAST MEDIA. WRONG PATIENT OR DEVICE SELECTION. PATIENT NOT FOLLOWING REHAB PROCEDURE. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED SEVERE SWELLING AND LACK OF MOBILITY AFTER THE DEVICE WAS IMPLANTED IN SHOULDER. THERE WAS POSITIVE CULTURE TEST WITH CUTIEBACTERIUM ACNES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED SEVERE SWELLING AND LACK OF MOBILITY AFTER THE DEVICE WAS IMPLANTED IN SHOULDER. THERE WAS POSITIVE CULTURE TEST WITH CURTIBACTERIUM ACNES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779999 INSPACE US LARGE SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB QPQ ORTHOSPACE LTD. UNKNOWN 17290013396065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other