BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUGRIP CMC IMPLANT

    MDR report key: 2230675 · Received August 12, 2011

    Report

    Report Number
    1651501-2011-00063
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYI
    PMA / PMN Number
    K041451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED AND NOTHING WAS IDENTIFIED IN THOSE RECORDS OF WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DEVICE WAS KEPT BY THE PATIENT AND IS NOT BEING RETURNED FOR ANALYSIS. THE INVESTIGATION AT THIS TIME HAS NOT IDENTIFIED A FINAL CONCLUSION BUT IT IS SPECULATED THAT BECAUSE OF THE LENGTH OF TIME BETWEEN IMPLANT AND THE REMOVAL OF THE DEVICE, THAT THE PAIN COULD BE RELATED TO THE SURGICAL PROCEDURE OR PATIENT PHYSIOLOGY. THE INVESTIGATION IS ONGOING AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENT REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MORE PAIN WITH THE CMC JOINT AFTER SURGERY. THE IMPLANT WAS REMOVED SHORTLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUGRIP CMC IMPLANT WRIST JOINT CARPAL TRAPEZIUM PROSTHESIS KYI ASCENSION ORTHOPEDICS, INC. NUG-433-30M 10-2008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R