BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D.4,5MM COMPRESSION SCREW L.23MM

    MDR report key: 22373102 · Received July 1, 2025

    Report

    Report Number
    3000931034-2025-00333
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 28, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    UDI-DI
    03700386930133
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (K030941) IS COMMERCIALLY AVAILABLE IN THE U.S.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. FROM THE PROVIDED PICTURE TAKEN JUST AFTER THE DEVICES EXPLANTATION (SOILED IMPLANTS), NO ADDITIONAL INFORMATION COULD BE OBSERVED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, A SHOULDER REVISION WAS PLANNED ON (B)(6) 2025 FOR INFECTION. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, A SHOULDER REVISION WAS PLANNED ON (B)(6) 2025 FOR INFECTION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418752 D.4,5MM COMPRESSION SCREW L.23MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. 8014AS 03700386930133

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention