BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STER. TI SCREW AND LOCK SCREW - 3.5MMX30MM LGT

    MDR report key: 2550828 · Received April 23, 2012

    Report

    Report Number
    9615741-2012-00027
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 23, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT POST OPERATIVE X-RAYS OF THE LOWER LEFT LEG AND FOOT TIBIAXYS ANTERIOR PLATING SYSTEM SHOWED THAT THE SCREW END CAP HAD BECOME LOOSE SOME TIME AFTER IMPLANTATION. THE X-RAY ALSO SHOWED THAT OTHER SCREWS THAT HAD BEEN INSERTED WITH THE TIBIAXYS ANTERIOR PLATING SYSTEM 150010 LOT NUMBER EC99, AND 150020 LOT NUMBER EDV6 HAD BROKEN OR BACKED OUT A LITTLE. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STER. TI SCREW AND LOCK SCREW - 3.5MMX30MM LGT N/A HWC NEWDEAL SAS FOHW

    Patients

    Seq Age Sex Outcome Treatment
    1