BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPACE US MEDIUM

    MDR report key: 23516135 · Received November 10, 2025

    Report

    Report Number
    3016573902-2025-00005
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 25, 2025
    Report Date
    April 3, 2026
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    QPQ
    UDI-DI
    17290013396058
    PMA / PMN Number
    DEN200039
    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

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. 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: DEPLOYER FRAGMENTATION PROBABLE ROOT CAUSE: APPLICATION - EXCESSIVE FORCE DURING INSERTION OR POSITIONING - INCORRECT SIZE SELECTION - PREMATURE RELEASE OF BACK STOPPER - INCISION TOO SMALL - POOR VISUALIZATION - DIFFICULT ANATOMY - WRONG PATIENT SELECTION. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE RECOMMENDED AMOUNT OF SALINE INTO A SIZE MEDIUM INSPACE BALLOON, IT WAS NOTICED THAT THE METAL TIP OF THE INSERTER HAD BROKEN OFF INTO THE BALLOON. THE BALLOON WAS THEN REMOVED AND ANOTHER BALLOON WAS INSERTED IT WAS ALSO A SIZE MEDIUM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTING THE RECOMMENDED AMOUNT OF SALINE INTO A SIZE MEDIUM INSPACE BALLOON, IT WAS NOTICED THAT THE METAL TIP OF THE INSERTER HAD BROKEN OFF INTO THE BALLOON. THE BALLOON WAS THEN REMOVED AND ANOTHER BALLOON WAS INSERTED IT WAS ALSO A SIZE MEDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40429 INSPACE US MEDIUM SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER ENDOSCOPY-SAN JOSE 080425-03 17290013396058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown