BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEIBINGER LOW PROFILE TITANIUM PLATE

    MDR report key: 8743880 · Received June 28, 2019

    Report

    Report Number
    0008031020-2019-00754
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    January 1, 1996
    Report Date
    June 28, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE FROM (B)(6). THE TITLE OF THIS REPORT IS ¿LOW-PROFILE PLATE FIXATION IN ARTHRODESIS OF THE FIRST METACARPOPHALANGEAL JOINT¿ WHICH WAS PUBLISHED IN FEBRUARY 2011 AND IS ASSOCIATED WITH THE STRYKER VARIAX HAND PLATING SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1996 TO 2003. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE AND/OR PATIENT INFORMATION FROM THE ARTICLE, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 7 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES DISCOMFORT. 1 OUT OF 2 CASES. THE STUDY STATES THAT ¿TWO PLATES CAUSED DISCOMFORT, WHICH WAS RELIEVED BY REMOVAL OF THE PLATE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538192 UNKNOWN LEIBINGER LOW PROFILE TITANIUM PLATE IMPLANT JEY STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention