BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US MEDIUM

    MDR report key: 14778111 · Received June 22, 2022

    Report

    Report Number
    0002936485-2022-00382
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 9, 2022
    Report Date
    September 14, 2022
    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
    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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INCORRECT FDA REGISTRATION NUMBER WAS USED DURING THE INITIAL REPORT. THE CORRECT FDA REGISTRATION NUMBER IS 3016573902. THE MANUFACTURE DATE IS NOT KNOWN. 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 FACTORS CHILLS AND FEVER PROBABLE ROOT CAUSE: DESIGN: - WRONG RAW MATERIAL OR MANUFACTURING AGENT SELECTED. - IN-PROCESS CLEANING NOT EFFECTIVE AT REMOVING MANUFACTURING RESIDUALS. - NOT ENOUGH STRICT CONTROLS PLACED ON RAW MATERIAL SOURCE AND PURITY. PROCESS: - STERILIZATION FAULT - INCLUDING ETO RESIDUALS. - CONTAMINATION DURING MANUFACTURING PROCESS; INCLUDING ENDOTOXINS. - IN-PROCESS CLEANING NOT PERFORMED TO SPEC. APPLICATION: - CONTAMINATION OF INSTRUMENTS. - PATIENT REACTION/ALLERGY SENSITIVITY OR WITH ACTIVE/LATENT INFECTION. - USE OF CONTRAST MEDIA. - USE OF MORE THAN ONE IMPLANT WITHIN THE SHOULDER. - WRONG PATIENT SELECTION. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND REQUIRED A WASH OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND REQUIRED A WASH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308194 INSPACE US MEDIUM SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER ENDOSCOPY-SAN JOSE 0131 140921-09 17290013396058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other