BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIDER PLATE AND SCREWS

    MDR report key: 2094115 · Received May 9, 2011

    Report

    Report Number
    3004608878-2011-00066
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 9, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT IT WAS OBSERVED ON RADIOGRAPHS THAT A SCREW IN THE IMPLANTED SPIDER LIMITED WRIST FUSION SYSTEM HAD BACKED OUT OF THE PLATE. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY TO REMOVE THE PLATED. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER PLATE AND SCREWS SPIDER LIMITED WRIST FUSION SYSTEM HRS INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention