BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D.4,5MM COMPRESSION SCREW L.32MM

    MDR report key: 15815121 · Received November 17, 2022

    Report

    Report Number
    3000931034-2022-00369
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    October 21, 2022
    Report Date
    January 19, 2023
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (# VDV218) IS COMMERCIALLY AVAILABLE CLEARED UNDER 510K # K030941. DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THE CORRECTIONS TO THE G1 MANUFACTURING SITE: THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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 AS WELL AS THE AFFECTED DEVICE 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 THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST PROCEDURE. AN EXPLORATION SURGERY REVEALED THAT THERE WAS AN INFECTION. THE FIRST REVISION WAS COMPLETED WITH A WASH OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST PROCEDURE. AN EXPLORATION SURGERY REVEALED THAT THERE WAS AN INFECTION. THE FIRST REVISION WAS COMPLETED WITH A WASH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178497 D.4,5MM COMPRESSION SCREW L.32MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. AD7994024

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention