BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 19930885 · Received August 7, 2024

    Report

    Report Number
    3016573902-2024-00006
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    May 1, 2023
    Report Date
    October 14, 2024
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. THE PART NUMBER IS NOT KNOWN AT THIS TIME, THEREFORE THE GTIN AND 510 IS NOT KNOWN. 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, AS MULTIPLE ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: POST-OPERATIVE DISPLACEMENT OF THE DEVICE. PROBABLE ROOT CAUSE: PROCESS: SPACER OR PLUG NOT MANUFACTURED TO SPECIFICATION. INCORRECT SIZE SPACER WITHIN PACKAGE. APPLICATION IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION; USER NOT FAMILIAR WITH DEVICE; INCORRECT SPACER SIZE SELECTION; SPACER CONTACT WITH OTHER IMPLANTS; USER UNDERINFLATED OR OVERINFLATED SPACER; PATIENT NONCOMPLIANT WITH POST-OP REHABILITATION SCHEDULE OR EXPOSED TO TOO INTENSIVE PT; USE OF MORE THAN ONE SPACER WITHIN JOINT; INCORRECT SPACER POSITIONING IN-SITU. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    PER PUBLICATION BY EHUD ATOUN, "SUBACROMIAL BALLOON SPACER FOR IRREPARABLE ROTATOR CUFF TEAR TREATMENT SHOWS IMPROVED PAIN AND STRENGTH AT 5-YEAR FOLLOW-UP", IT WAS REPORTED THERE BALLOON DISLOCATION OCCURRED IN 1 PATIENT. BECAUSE OF BALLOON DISLOCATION, THE PATIENT EXPERIENCED DISCOMFORT, AND AN OFFICE-BASED PERCUTANEOUS PUNCTURE OF THE BALLOON WAS PERFORMED.

    Description of Event or Problem · 0

    PER PUBLICATION BY EHUD ATOUN, "SUBACROMIAL BALLOON SPACER FOR IRREPARABLE ROTATOR CUFF TEAR TREATMENT SHOWS IMPROVED PAIN AND STRENGTH AT 5-YEAR FOLLOW-UP", IT WAS REPORTED THERE BALLOON DISLOCATION OCCURRED IN 1 PATIENT. BECAUSE OF BALLOON DISLOCATION, THE PATIENT EXPERIENCED DISCOMFORT, AND AN OFFICE-BASED PERCUTANEOUS PUNCTURE OF THE BALLOON WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220631 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