BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VARIAX 2 VOLAR MEDIAL RIM DR PLATE, LONG

    MDR report key: 23121377 · Received September 23, 2025

    Report

    Report Number
    0008031020-2025-01616
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 23, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (SCS) NAMED "A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF WRIST FRACTURES WITH THE VARIAX 2 DISTAL RADIUS SYSTEM AND VARIAX 2 DISTAL ULNA SYSTEM" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF VARIAX 2 DISTAL RADIUS SYSTEM AND VARIAX 2 DISTAL ULNA SYSTEM. THE DATA COLLECTION PERIOD WAS FROM SEPTEMBER 2023 TO MAY 2025. 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: INFECTION OF DEEP INCISIONAL SURGICAL SITE TREATED WITH EXCISIONAL DEBRIDEMENT SKIN, TENDON, AND WRIST WHICH RESULTED IN HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733481 UNKNOWN VARIAX 2 VOLAR MEDIAL RIM DR PLATE, LONG PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention