BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPACE IMPLANT - MEDIUM

    MDR report key: 23430610 · Received October 30, 2025

    Report

    Report Number
    3016573902-2025-00004
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    April 15, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    PMA / PMN Number
    DEN200039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: THE M BALLOON THAT WAS PLACED NEVER INFLATED. IT MOVED OUT OF POSITION, AND WHEN TRYING TO INFLATE IT OUTSIDE THE INTENDED AREA, THE SOLUTION WOULD LEAK OUT ¿ SO AN S BALLOON HAD TO BE USED INSTEAD. VISUAL INSPECTION: THE TIP OF THE OVERMOLDED TUBE WAS BROKEN. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE COULD BE USE OF EXCESSIVE FORCE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE M BALLOON THAT WAS PLACED NEVER INFLATED. IT MOVED OUT OF POSITION, AND WHEN TRYING TO INFLATE IT OUTSIDE THE INTENDED AREA, THE SOLUTION WOULD LEAK OUT. SO, AN S BALLOON HAD TO BE USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379298 INSPACE IMPLANT - MEDIUM SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ ORTHOSPACE LTD. 040723-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male