BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCP SZ. 30 PROXIMAL WW

    MDR report key: 3231367 · Received July 15, 2013

    Report

    Report Number
    1651501-2013-00020
    Event Type
    Injury
    Date Received
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    NEG
    PMA / PMN Number
    P000057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL SURGERY ON HIS RIGHT HAND (INDEX AND MIDDLE FINGERS) FOR ARTHRITIS ON (B)(6) 2012. THE PATIENT EXPERIENCED PAIN (ON AN UNKNOWN DATE) AND AN X-RAY OF THE RIGHT HAND WAS PERFORMED WHICH SHOWED A FRACTURE IN THE DISTAL TIP OF THE PROXIMAL IMPLANT AND THE BONE OF HIS MIDDLE FINGER OF THE RIGHT HAND. NO RELATED TRAUMA OR INJURY WAS REPORTED. THE PATIENT UNDERWENT SURGERY AND THE IMPLANT WAS REMOVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326760 MCP SZ. 30 PROXIMAL WW NEG ASCENSION ORTHOPEDICS 120027 OR 120030

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention