BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED HEMI IMPLANT

    MDR report key: 2095050 · Received May 12, 2011

    Report

    Report Number
    2027754-2011-00002
    Event Type
    Injury
    Date Received
    May 12, 2011
    Report Date
    May 11, 2011
    Manufacturer
    OSTEOMED L.P.
    Product Code
    KWD
    PMA / PMN Number
    K060536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVAL. MULTIPLE REQUESTS FOR INFO HAVE GONE UNANSWERED.

    Description of Event or Problem · 1

    PT RECEIVED A HEMI IMPLANT ON (B)(6) 2011. PT'S TOE WAS RED AND WARM TO TOUCH. THE PT HAD BEEN ON ORAL ANTIBIOTICS FOR SEVERAL WEEKS BEFORE THE EXPLANT. PT RECEIVED ANTIBIOTIC BEADS AND A MINI RAIL EXTERNAL FIXATOR. MULTIPLE REQUESTS FOR INFO ON CULTURES AND TREATMENT HAVE NOT BEEN ANSWERED. PT ALLEGEDLY COMPLIANT. PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. REVIEW OF COMPLAINT HISTORY DATABASE SHOWS NO SIMILAR RESULTS OR ISSUES FOR THIS PRODUCT. DEVICE HISTORY RECORD SHOWS PRODUCT WAS MANUFACTURED AND STERILIZED IN ACCORDANCE WITH REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED HEMI IMPLANT PROSTHESIS, TOE, HEMI, PHALANGEAL KWD OSTEOMED L.P. 375-0003 10286551

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention