BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US MEDIUM

    MDR report key: 16591959 · Received March 22, 2023

    Report

    Report Number
    3016573902-2022-00006
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    November 18, 2022
    Report Date
    June 2, 2023
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    QPQ
    UDI-DI
    17290013396058
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: PATIENT 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; RE-USE OF SINGLE-USE DEVICE; USE OF CONTRAST MEDIA; WRONG PATIENT OR DEVICE SELECTION; PATIENT NOT FOLLOWING REHAB PROCEDURE. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. 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. CORRECTION: THE CORRECT FDA REGISTRATION NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PATIENT PAIN THAT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PATIENT PAIN THAT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496123 INSPACE US MEDIUM SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER ENDOSCOPY-SAN JOSE 0131 290322-06 17290013396058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other