BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE IMPLANT - LARGE

    MDR report key: 23923620 · Received December 30, 2025

    Report

    Report Number
    3016573902-2025-00006
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CORRECT IMPLANTATION ON (B)(6) 2025, THE INSPACE BALLOON DISPLACED LATERALLY UNDER THE DELTOID MUSCLE. IT IS UNKNOWN WHEN THE DISLOCATION OCCURRED; IT WAS ONLY NOTICED DURING THE FOLLOW-UP EXAMINATION ON (B)(6) 2025. PER ADDITIONAL INFORMATION RECEIVED ON 18DEC2025, THE DEVICE NEEDED TO BE AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887493 INSPACE IMPLANT - LARGE SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ ORTHOSPACE LTD. 251223-01

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other