BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 17446828 · Received August 2, 2023

    Report

    Report Number
    3016573902-2023-00004
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    October 1, 2022
    Report Date
    March 22, 2024
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE CATALOG NUMBER IS NOT KNOWN AT THIS TIME, THEREFORE THE GTIN COULD NOT BE DETERMINED. 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. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: POOR RESULTS AFTER ARTHROSCOPIC TREATMENT OF IRREPARABLE ROTATOR CUFF TEARS USING A SUBACROMIAL BALLOON SPACER PROBABLE ROOT CAUSE: APPLICATION INCORRECT SPACER SIZE SELECTION PATIENT NONCOMPLIANT WITH POST-OP REHABILITATION SCHEDULE OR EXPOSED TO TOO INTENSIVE PT USER UNDERINFLATED OR OVERINFLATED SPACER MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WITHIN A PUBLICATION BY (B)(6) THAT THE PATIENT HAD A BALLOON MIGRATION AND AN MRI SCAN CONFIRMED ANTERIOR MIGRATION OF THE BALLOON. THEY ALSO HAD LOCAL WARMTH AND SWELLING IN THE ANTERIOR ASPECT OF THE SHOULDER. GIVEN THE PERSISTENCE OF SYMPTOMS, AN OPEN SURGERY BY AN ANTEROSUPERIOR APPROACH WAS CONDUCTED REMOVING THE BALLOON.

    Description of Event or Problem · 0

    IT WAS REPORTED WITHIN A PUBLICATION BY DANIEL GARRIGUEZ-PEREZ THAT THE PATIENT HAD A BALLOON MIGRATION AND AN MRI SCAN CONFIRMED ANTERIOR MIGRATION OF THE BALLOON. THEY ALSO HAD LOCAL WARMTH AND SWELLING IN THE ANTERIOR ASPECT OF THE SHOULDER. GIVEN THE PERSISTENCE OF SYMPTOMS, AN OPEN SURGERY BY AN ANTEROSUPERIOR APPROACH WAS CONDUCTED REMOVING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658897 UNKNOWN_ORTHOSPACE_PRODUCT SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB QPQ ORTHOSPACE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other