BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATE

    MDR report key: 16425864 · Received February 23, 2023

    Report

    Report Number
    0008031020-2023-00092
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    July 9, 2021
    Report Date
    February 23, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE AWARENESS DATE OF THIS EVENT WAS INCORRECTLY SUBMITED AND SHOULD HAVE BEEN (B)(6)-2021.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE FAILED DUE TO INFECTION AND NONUNION. ALL HARDWARE WAS REMOVED EXCEPT FOR TWO DISTAL LAG SCREWS AND A 12X380 STRYKER OLD SCN NAIL AND LATERAL LOCKING PLATE WAS INSERTED. BY END OF MONTH IT WAS INFECTED AGAIN AND PATIENT WENT BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE FAILED DUE TO INFECTION AND NONUNION. ALL HARDWARE WAS REMOVED EXCEPT FOR TWO DISTAL LAG SCREWS AND A 12X380 STRYKER OLD SCN NAIL AND LATERAL LOCKING PLATE WAS INSERTED. BY END OF MONTH IT WAS INFECTED AGAIN AND PATIENT WENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864088 UNKNOWN PLATE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention