BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP, SCN T2 SCN

    MDR report key: 11207338 · Received January 21, 2021

    Report

    Report Number
    0009610622-2021-00241
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 25, 2020
    Report Date
    January 21, 2021
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540378613
    PMA / PMN Number
    K023267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE FOR RETURN, DEVICE IS STILL IMPLANTED.

    Description of Event or Problem · 1

    AS REPORTED; "ABOUT 10 YEARS AGO, THE PATIENT INSERTED A T2 SUPRA CONDILLA NAIL AT ANOTHER HOSPITAL, AND OVER THE YEARS, THE END CAP HAD FALLEN OFF AND WAS IN THE JOINT. ADDITIONAL INFORMATION RECEIVED: DID THE LOOSE CAP HAD BEEN LOOSE IN THE JOINT DURING THE LAST 10 YEARS OR MORE RECENTLY? IT LOOSEN RECENT YEARS. ANY PLANS FOR MEDICAL INTERVENTION TO REMOVE THE END CAP? THE INFORMATION IS UNAVAILABLE, IF THE END CAP IS GOING TO REMOVE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107490 END CAP, SCN T2 SCN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL 1826-0003S UNKNOWN 04546540378613

    Patients

    Seq Age Sex Outcome Treatment
    1