BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSS PLATE MTP, RIGHT ANCHORAGE

    MDR report key: 20771090 · Received November 25, 2024

    Report

    Report Number
    0008031020-2024-00630
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 5, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252473343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. (REGISTERED UNDER 510(K)# K083447). THEREFORE, IT IS SUBJECT TO REPORTABILITY UNDER MDR. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: PLEASE REFER TO SECTION D9 THE DEVICE WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. MORE INFORMATION SUCH PATIENT¿S MEDICAL RECORDS AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE ISSUE. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT WAS BOOKED FOR REMOVAL OF PLATE BUT I DIDN¿T KNOW IT HAD SNAPPED INSIDE UNTIL THE DAY OF REMOVAL. PLATE WAS REMOVED (B)(6) 2024 ¿ ORIGINAL SURGERY DATE (B)(6) 2023 PLATE WAS REPLACED."

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT WAS BOOKED FOR REMOVAL OF PLATE BUT I DIDN¿T KNOW IT HAD SNAPPED INSIDE UNTIL THE DAY OF REMOVAL. PLATE WAS REMOVED (B)(6) 2024 ¿ ORIGINAL SURGERY DATE (B)(6) 2023. PLATE WAS REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708332 CROSS PLATE MTP, RIGHT ANCHORAGE PLATE, FIXATION, BONE HRS STRYKER GMBH AA0794 07613252473343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention