BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN VARIAX PLATE

    MDR report key: 13690810 · Received March 8, 2022

    Report

    Report Number
    0008031020-2022-00089
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    January 22, 2018
    Report Date
    March 7, 2022
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF EVENTS SUMMARIZED AS PART OF LITERATURE REVIEW, WHEN DEVICE AND PATIENT INFORMATION IS NOT AVAILABLE. THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED 2 PATIENTS THAT EXPERIENCED HAIRLINE FRACTURES SURROUNDING THE PROXIMAL PART OF THE PLATE AS MENTIONED IN THE LITERATURE COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER 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 BECAME AWARE OF A LITERATURE PUBLISHED BY HAND SURGERY UNIT, DIVISION OF ORTHOPAEDIC SURGERY, TEL AVIV SOURASKY MEDICAL CENTER, SACKLER FACULTY OF MEDICINE. THE TITLE OF THIS REPORT IS ¿HAIRLINE FRACTURES FOLLOWING VOLAR PLATING OF THE DISTAL RADIUS: A RECENTLY RECOGNIZED HARDWARE-RELATED COMPLICATION¿ PUBLISHED ON JANUARY 22 2018, WHICH IS ASSOCIATED WITH THE STRYKER ¿VARIAX PLATING¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1007/S00256-018-2877-9. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 220 PATIENTS, THE CASES IN THIS STUDY RANGE FROM JUNE 2013 AND JUNE 2015. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH SPECIFIC DEVICE DETAILS, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 2 PATIENTS EXPERIENCED HAIRLINE FRACTURES SURROUNDING THE PROXIMAL PART OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654618 UNKNOWN VARIAX PLATE PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention