BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ 20 DISTAL

    MDR report key: 2428522 · Received January 19, 2012

    Report

    Report Number
    1651501-2012-00005
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    January 5, 2011
    Report Date
    January 19, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS INITIALLY IMPLANTED WITH A PIP IMPLANT ON (B)(6) 2009. A REVISION WAS DONE ON (B)(6) 2011 FOR A BOUTONNIERE TYPE DEFORMITY OF THE LEFT MIDDLE FINGER. THE DEVICE WAS REMOVED TO CORRECT THE DEFORMITY ITSELF. THE DEVICE WAS NOT DEFECTIVE AND THE SAME DEVICE THAT WAS REMOVED WAS IMPLANTED AGAIN INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ 20 DISTAL PIP KYJ ASCENSION ORTHOPEDICS 08-0855

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention