BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 16590691 · Received March 22, 2023

    Report

    Report Number
    3016573902-2022-00003
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    July 27, 2021
    Report Date
    June 19, 2023
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    PMA / PMN Number
    200039
    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

    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: CONTINUES SHOULDER PAIN 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE THE DEVICE DUE TO INSUFFICIENT CLINICAL IMPROVEMENT AND PATIENT PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE THE DEVICE DUE TO INSUFFICIENT CLINICAL IMPROVEMENT AND PATIENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496052 UNKNOWN_ORTHOSPACE_PRODUCT SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ ORTHOSPACE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other