BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 20292321 · Received September 24, 2024

    Report

    Report Number
    3016573902-2024-00008
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    July 17, 2024
    Report Date
    November 18, 2025
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PATIENT PAIN. PROBABLE ROOT CAUSE: APPLICATION: CONTAMINATION OF INSTRUMENTS, PATIENT REACTION/ALLERGY SENSITIVITY OR WITH ACTIVE/LATENT INFECTION, USE OF CONTRAST MEDIA, USE OF MORE THAN ONE IMPLANT WITHIN THE SHOULDER, WRONG PATIENT SELECTION AND GENERAL REACTION TO PROCEDURE.

    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 3 WEEKS POST INSPACE IMPLANTATION THE PATIENT DEVELOPED WORSENING PAIN REQUIRING TWO EMERGENCY DEPARTMENT VISITS. CT REVEALED LARGE ENHANCING SHOULDER JOINT EFFUSION. LEFT SHOULDER JOINT ASPIRATED CELL COUNT SHOWED A LEFT SHIFT WITH 93.6% POLYMORPHONUCLEAR CELLS. BALLOON WAS EXPLANTED WHICH APPEARED TO BE A DECOMPRESSED APPEARANCE. THIS IS FILLED WITH APPROXIMATELY 0.5 CC OF AMBER HAZY FLUID. UPON CAREFUL EXAM NO PUNCTURES OR TEARS WERE GROSSLY VISIBLE. UPON CAREFUL PALPATION OF THE ENTIRE SURFACE OF THIS DEVICE AIR BUBBLES AND FLUID WERE DISCHARGED AT AN APPROXIMATELY 0.2 CM AREA OF THE PROBABLE SEAM OF THIS DEVICE. NO OTHER AREAS OF LEAKAGE WERE NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 WEEKS POST INSPACE IMPLANTATION THE PATIENT DEVELOPED WORSENING PAIN REQUIRING TWO EMERGENCY DEPARTMENT VISITS. CT REVEALED LARGE ENHANCING SHOULDER JOINT EFFUSION. LEFT SHOULDER JOINT ASPIRATED CELL COUNT SHOWED A LEFT SHIFT WITH 93.6% POLYMORPHONUCLEAR CELLS. BALLOON WAS EXPLANTED WHICH APPEARED TO BE A DECOMPRESSED APPEARANCE. THIS IS FILLED WITH APPROXIMATELY 0.5 CC OF AMBER HAZY FLUID. UPON CAREFUL EXAM NO PUNCTURES OR TEARS WERE GROSSLY VISIBLE. UPON CAREFUL PALPATION OF THE ENTIRE SURFACE OF THIS DEVICE AIR BUBBLES AND FLUID WERE DISCHARGED AT AN APPROXIMATELY 0.2 CM AREA OF THE PROBABLE SEAM OF THIS DEVICE. NO OTHER AREAS OF LEAKAGE WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139124 UNKNOWN_ORTHOSPACE_PRODUCT SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB QPQ ORTHOSPACE LTD. 130922-03

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other