BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED LAPIDUS PLATE

    MDR report key: 2441142 · Received February 2, 2012

    Report

    Report Number
    2027754-2012-00004
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 3, 2012
    Report Date
    February 2, 2012
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAD POOR BONE STOCK. THE INSTRUCTIONS FOR USE STATE THAT THE PRODUCT IS CONTRAINDICATED IN PTS WHO HAVE INSUFFICIENT BONE OR POOR BONE QUALITY. THE OSTEOMED FOOT PLANTING SYSTEM IS RECOMMENDED FOR USE IN PTS WITH SUFFICIENT BONE QUALITY TO SUSTAIN EFFECTIVENESS AND BENEFITS OF RIGID FIXATION. THE OSTEOMED FOOT PLANTING SYSTEM IMPLANTS ARE NOT INTENDED TO ENDURE EXCESSIVE ABNORMAL FUNCTIONAL STRESSES. THE OSTEOMED FOOT PLANTING SYSTEM IS INTENDED FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCURS. REVIEW OF LOT MFG HISTORY DOES NOT SHOW ANY NONCONFORMANCES FOR THIS LOT.

    Description of Event or Problem · 1

    PT RECEIVED IMPLANT IN (B)(6) 2011. INITIAL POST-OP X-RAY AND FIRST TWO VISITS, WERE UNEVENTFUL. SIX WEEKS AFTER SURGERY, PT CAME IN COMPLAINING OF PAIN. X-RAY SHOWED THAT THE PLATE HAD BROKEN. THERE WERE NO SIGNS OF BONE HEALING AFTER 6 WEEKS. SURGEON COMMENTED ON PT'S POOR BONE STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED LAPIDUS PLATE 2.7 MM LAPIDUS PLATE RIGHT HRS OSTEOMED 324-1290 1036647

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention