BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPACE US LARGE

    MDR report key: 14688862 · Received June 14, 2022

    Report

    Report Number
    0002936485-2022-00324
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 3, 2022
    Report Date
    February 7, 2023
    Manufacturer
    ORTHOSPACE LTD.
    Product Code
    QPQ
    UDI-DI
    17290013396065
    PMA / PMN Number
    DEN200039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    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. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PATIENT HAD INFECTION 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 PRODUCT WAS NOT RECEIVED IN-HOUSE AT ORTHOSPACE-STRYKER ENDOSCOPY, AND REPORTABILITY DECISION WAS CHECKED FOR CONSISTENCY.

    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. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: PATIENT HAD INFECTION 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 MANUFACTURE DATE IS NOT KNOWN.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813334 INSPACE US LARGE SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL QPQ ORTHOSPACE LTD. 0132 291121-04 17290013396065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other