BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 17444287 · Received August 2, 2023

    Report

    Report Number
    3016573902-2023-00007
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    May 1, 2020
    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: PATIENT SYNOVITIS. PROBABLE ROOT CAUSE: DESIGN: - INADEQUATE RAW MATERIAL SPECIFICATION. PROCESS: - SPACER NOT MANUFACTURED TO SPECIFICATION. - INCORRECT MATERIAL USED DURING MANUFACTURE. - INCORRECT PACKAGING OR ERROR IN PACKAGING PROCESS CAUSES EXPOSURE TO HUMIDITY OR HIGH TEMPERATURES. APPLICATION: - USE OF EXPIRED PRODUCT. - WRONG STORAGE CONDITIONS (HIGH TEMPERATURES OR EXPOSURE TO HUMIDITY <40%). - RE-USE OF SINGLE-USE DEVICE. - USE OF CONTRAST MEDIA. - WRONG PATIENT OR DEVICE SELECTION. - PATIENT NOT FOLLOWING REHAB PROCEDURE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED WITHIN A PUBLICATION BY ARISTOTELIS KAISIDIS THAT THE PATIENT PRESENTED "SYNOVITIS, SUPERFICIAL WOUND ERYTHEMA, AND DETERIORATION IN RANGE OF MOTION. REMOVAL OF THE INSPACE DEVICE ARTHROSCOPICALLY, WITHOUT ANY OTHER INTERNAL SIGNS OF INFECTION."

    Description of Event or Problem · 0

    IT WAS REPORTED WITHIN A PUBLICATION BY ARISTOTELIS KAISIDIS THAT THE PATIENT PRESENTED "SYNOVITIS, SUPERFICIAL WOUND ERYTHEMA, AND DETERIORATION IN RANGE OF MOTION. REMOVAL OF THE INSPACE DEVICE ARTHROSCOPICALLY, WITHOUT ANY OTHER INTERNAL SIGNS OF INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385177 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