BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STER. CORT. SCREW - 4MM DIAM X 65MM LONG

    MDR report key: 2434323 · Received January 27, 2012

    Report

    Report Number
    9615741-2012-00003
    Event Type
    Injury
    Date Received
    January 27, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 27, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 A PATIENT HAD A LOWER EXTREMITY SURGICAL PROCEDURE IN (B)(6), 2012 FOR AN ANKLE ARTHRODESIS. THE PATIENT HAD A LOT OF PAIN FOLLOWING THE PROCEDURE, AND UPON FOLLOW UP X-RAY, THE SURGEON BELIEVED THAT A FEW OF THE SCREWS WERE TOO LONG. THE PROCEDURE WAS REVISED ON (B)(6), 2012 TO REPLACE SOME OF THE SCREWS. WHEN THE SURGEON WAS REMOVING THE IMPLANTED SCREWS, THE CONNECTION BETWEEN THE SCREWDRIVER AND THE SCREW HEAD WAS NOT TIGHT AND THE HEAD OF THE SCREW WAS SHEARING OFF. THE SURGEON WAS ABLE TO REMOVE THE SCREWS BY APPLYING FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STER. CORT. SCREW - 4MM DIAM X 65MM LONG NA HWC NEWDEAL SAS EA1G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention