BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPHLEX IPJ

    MDR report key: 855604 · Received May 25, 2007

    Report

    Report Number
    2027754-2007-00005
    Event Type
    Injury
    Date Received
    May 25, 2007
    Date of Event
    March 9, 2007
    Report Date
    May 25, 2007
    Manufacturer
    OSTEOMED L.P.
    Product Code
    LZJ
    Report Source
    Manufacturer report
    Reporter Occupation
    DPM

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TELEPHONE CALL WITH DR. HE STATED THAT "POST OP THE TOE DISLOCATED AND TOOK THE STEM WITH IT, BREAKING IMPLANT."

    Description of Event or Problem · 1

    A MALE WITH HX OF DISLOCATED TOE AND HAMMERTOE. DR PERFORMED IMPLANT IN 2004. IN 2007, IMPLANT WAS REMOVED BECAUSE IT HAD BROKEN. PT CURRENTLY DOING FINE - NOT IN PAIN. AT TIME OF SURGERY SURGEON LOOSENED TENDONS AS REQUIRED. NO HISTORY OF PT. TRAUMA TO TOE. PT HAMMERTOE REOCCURRED BEFORE EXPLANT - POSSIBLY DUE TO PT'S NATURAL ANATOMY OR THE FACT THAT MORE OF A TENDON LENGTHENING/CAPSULOTOMY WAS NEEDED AT INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPHLEX IPJ INTERPHALANGEAL SPACER LZJ OSTEOMED L.P. 360-2808 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention BUNIONECTOMY