BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US LARGE

    MDR report key: 14349738 · Received May 10, 2022

    Report

    Report Number
    0002936485-2022-00222
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 12, 2022
    Report Date
    October 25, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    QPQ
    UDI-DI
    17290013396065
    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

    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

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. HOWEVER IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS. IN THE EVENT THAT FURTHER INFORMATION IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: MATERIAL ELICITS PHYSIOLOGICAL ADVERSE REACTION 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 PROBABLE ROOT CAUSE: DESIGN - INADEQUATE RAW MATERIAL SPECIFICATION PROCESS - INCORRECT MATERIAL USED DURING MANUFACTURE APPLICATION - IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION OR PATIENT PRE-CONDITIONS - USE OF EXPIRED PRODUCT - RE-USE OF SINGLE-USE DEVICE - USE OF CONTRAST MEDIA - DEGRADATION ACCELERATED BY INFLAMMATORY REACTION - PATIENT NOT FOLLOWING REHAB PROTOCOL THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INCORRECT FDA REGISTRATION NUMBER WAS USED DURING THE INITIAL REPORT. THE CORRECT FDA REGISTRATION NUMBER IS 3016573902. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. HOWEVER IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS, WHICH IS A CLINICAL CONDITION THAT ASSOCIATED WITH IMMUNE DISORDER AND CAN CONTRIBUTE TO THE DEVELOPMENT OF INFECTION POST DEVICE IMPLANTATION. IN THE EVENT THAT FURTHER INFORMATION IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: MATERIAL ELICITS PHYSIOLOGICAL ADVERSE REACTION. 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. PROBABLE ROOT CAUSE: DESIGN. INADEQUATE RAW MATERIAL SPECIFICATION. PROCESS: INCORRECT MATERIAL USED DURING MANUFACTURE. APPLICATION: IMPLANT USED IN CONTRAINDICATED OR ILL-ADVISED PATIENT POPULATION OR PATIENT PRE-CONDITIONS. USE OF EXPIRED PRODUCT. RE-USE OF SINGLE-USE DEVICE. USE OF CONTRAST MEDIA. DEGRADATION ACCELERATED BY INFLAMMATORY REACTION. PATIENT NOT FOLLOWING REHAB PROTOCOL. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED SHOULDER REQUIRING AN ARTHROSCOPIC WASH OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED SHOULDER REQUIRING AN ARTHROSCOPIC WASH OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD SHOULDER PAIN 4 MONTHS POST IMPLANTATION AND DIAGNOSED WITH AN INFECTED SHOULDER REQUIRING AN ARTHROSCOPIC WASH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100574 INSPACE US LARGE SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ STRYKER ENDOSCOPY-SAN JOSE 0132 010621-02 17290013396065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other