BEUDAMED
    FDA Adverse Event Other Summary report: N

    WRIST ARTHRODESIS NAIL SYSTEM

    MDR report key: 3022477 · Received March 15, 2013

    Report

    Report Number
    3006742481-2013-00004
    Event Type
    Other
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SKELETAL DYNAMICS LLC
    Product Code
    HSB
    PMA / PMN Number
    K092720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF EVENT. THERE ARE WARNINGS ON THE INSTRUCTIONS FOR USE THAT STATE THIS TYPE OF EVENT CAN OCCUR. UNDER "WARNINGS" THE FOLLOWING IS STATED: EVERY CONNECTOR MUST BE SECURED TO THE CONSTRUCT USING TWO (2) SETSCREWS (ONE AT EACH END FOR METACARPAL AND DISTAL RADIUS NAILS). IF EITHER OF THE SETSCREWS ARE NOT ATTACHED AND/OR FULLY TIGHTENED, A NON-UNION, DELAYED UNION OR CONSTRUCT FAILURE MAY OCCUR. THE SURGICAL TECHNIQUE REQUIRES THE COMPLETE DECORTICATION OF THE ARTICULAR SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS TO BE PERFORMED DUE TO THE LOOSENING OF THE DEVICE AND FUSION HAD NOT BEEN ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110826 WRIST ARTHRODESIS NAIL SYSTEM NONE HSB SKELETAL DYNAMICS LLC AZ0710021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other