BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION NUGRIP

    MDR report key: 1643696 · Received March 26, 2010

    Report

    Report Number
    1651501-2010-00011
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    January 21, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYI
    PMA / PMN Number
    K041451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS WERE REVIEWED. NOTHING IN THOSE RECORDS IDENTIFIED WHAT CAUSED OR CONTRIBUTED TO THIS EVENT. METHOD: MANUFACTURING RECORDS FOR THE IMPLANT WERE EXAMINED. THE CUSTOMER FEEDBACK RECORD WAS THEN REVIEWED TO UNDERSTAND THE SEQUENCE OF EVENTS THAT OCCURRED DURING IMPLANTATION AS RELATED BY THE USER AND ANY OTHER INFO PROVIDED BY THE FIELD. A VISUAL EXAMINATION OF THE IMPLANT WAS PERFORMED ASSISTED BY A STEREOMICROSCOPE AND OBLIQUE LIGHTING. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE SIZE 30M THB REVEALED THAT ALL APPLICABLE MANUFACTURING SPECIFICATIONS WERE SATISFIED.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF INCREASED PAIN 3 MONTHS AFTER IMPLANT SURGERY. THE PHYSICIAN DETERMINED THAT THERE WAS SUBSIDENCE AND A SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION NUGRIP CARPAL TRAPEZIUM PROSTHESIS KYI ASCENSION ORTHOPEDICS, INC. THB-442-3020-WW 08-1632

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R