BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US MEDIUM

    MDR report key: 19968454 · Received August 12, 2024

    Report

    Report Number
    3016573902-2024-00007
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    April 17, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    UDI-DI
    17290013396058
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: INSPACE BALLOON IMPLANT SHIFTED POSTERIORLY IN THE SUBACROMIAL SPACE 2 WEEKS POST OP PROBABLE ROOT CAUSE: PROCESS - SPACER OR PLUG NOT MANUFACTURED TO SPECIFICATION - INCORRECT SIZE SPACER WITHIN PACKAGE APPLICATION - IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION - USER NOT FAMILIAR WITH DEVICE - INCORRECT SPACER SIZE SELECTION - SPACER CONTACT WITH OTHER IMPLANTS - USER UNDERINFLATED OR OVERINFLATED SPACER - PATIENT NONCOMPLIANT WITH POST-OP REHABILITATION SCHEDULE OR EXPOSED TO TOO INTENSIVE PT - USE OF MORE THAN ONE SPACER WITHIN JOINT THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSPACE BALLOON IMPLANT SHIFTED POSTERIORLY IN THE SUBACROMIAL SPACE 2 WEEKS POST OP. THE BALLOON WAS DEFLATED UPON EXAMINATION PRIOR TO REMOVAL. THE BALLOON WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSPACE BALLOON IMPLANT SHIFTED POSTERIORLY IN THE SUBACROMIAL SPACE 2 WEEKS POST OP. THE BALLOON WAS DEFLATED UPON EXAMINATION PRIOR TO REMOVAL. THE BALLOON WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205826 INSPACE US MEDIUM SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB QPQ ORTHOSPACE LTD. 130922-03 17290013396058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other