BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ORTHOSPACE_PRODUCT

    MDR report key: 14377122 · Received May 12, 2022

    Report

    Report Number
    0002936485-2022-00239
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 13, 2022
    Report Date
    July 27, 2022
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    QPQ
    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. THE CATALOG NUMBER IS NOT KNOWN AT THIS TIME, THEREFORE THE GTIN IS ALSO UNKNOWN. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Additional Manufacturer Narrative · 0

    THE DEVICE MANUFACTURER 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. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: IMPLANT BROKE AND PATIENT INFLAMMATION. 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. H3 OTHER TEXT: 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFLAMMATORY REACTION AND THERE WAS A NEED FOR ANOTHER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFLAMMATORY REACTION AND THERE WAS A NEED FOR ANOTHER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956443 UNKNOWN_ORTHOSPACE_PRODUCT SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB QPQ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other