BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLUG EXTRACTOR T2 ICF

    MDR report key: 10550775 · Received September 17, 2020

    Report

    Report Number
    0009610622-2020-00527
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 17, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    07613327346466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    SURGEON TREATED A CHRONIC CHARCOT FOOT IN A BOTH COLUMNS PROCEDURE ON A PATIENT THAT HAD PREVIOUSLY BEEN TREATED WITH AN EXTERNAL FIXATOR. HIS FEEDBACK INCLUDED THE FOLLOWING: "THE 1ST MET BONE PLUG WE REMOVED WAS TOO LARGE. I THINK PRIOR TO RE-INSERTING YOU SHOULD MEASURE THE DEPTH + CUT TO SIZE. TRYING TO TAMP THE LARGE PLUG BACK IN DESTROYED THE CARTILAGE OF THE JOINT.¿ [PROVIDED AS A COMMENT ON ANY DISSATISFACTION WITH THE PRODUCTS AND PROCEDURE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011418 BONE PLUG EXTRACTOR T2 ICF ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL 2358-3200 UNKNOWN 07613327346466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other