BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PRO SUPRAPECTINEAL FLEX PLATE, 12- HOLE

    MDR report key: 23301163 · Received October 15, 2025

    Report

    Report Number
    0008031020-2025-01783
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    March 1, 2024
    Report Date
    October 14, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE(S) WERE NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SITE. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED STRYKER COLLABORATIVE STUDY NAMED "A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF PELVIS FRACTURES WITH THE PELVIS NEXT GENERATION PLATES OF THE PRO IMPLANTS SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PRO IMPLANTS (NEXT GENERATION PLATES). THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN JANUARY 2023 ¿ MARCH 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, THE FOLLOWING ADVERSE EVENT WAS REPORTED: SUBJECT 7 DEVELOPED A PSOAS ABSCESS AND PRESENTED WITH SEPSIS AND UNDERLYING INFECTIOUS DISEASE RESULTING IN A DEBRIDEMENT TO TREAT THE INFECTION SOURCE. PATIENT EXPIRED SEVERAL DAYS AFTER DEBRIDEMENT OPERATION. FATAL ADVERSE EVENT IS NOT ATTRIBUTED TO THE DEVICE IMPLANT BUT RELATED TO SEPSIS AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994137 UNKNOWN PRO SUPRAPECTINEAL FLEX PLATE, 12- HOLE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death