BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER

    MDR report key: 2816467 · Received November 2, 2012

    Report

    Report Number
    2520274-2012-02835
    Event Type
    Injury
    Date Received
    November 2, 2012
    Report Date
    October 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K974554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL INFORMATION. CORRECTED BRAND NAME FROM "1.5MM RAPID RESORBABLE ORBITALFLOOR PLATE 35MMX35MM-STERILE" TO "1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER." CATALOG #: CORRECTED PART NUMBER FROM "851.542.01S" TO "821.699.01S." THE 510K#: CORRECTED FROM "K030069" TO "K974554."

    Additional Manufacturer Narrative · 1

    IMPLANTED: (B)(6) 2012. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    PATIENT IMPLANTED AT MILLENIUM SURGERY CENTER IN (B)(6) 2012 WITH RESORBABLE ORBITAL PLATE. SURGEON WANTED TO TRIM PLATE AND SCHEDULED REVISION FOR (B)(6) 2012 AT ANOTHER HOSPITAL FACILITY. ON THE REVISION DATE, SURGEON DECIDED TO REMOVED THE PLATE AND SCREWS, THE FRACTURE WAS HEALED. NO NEW HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM RESORB ORBITAL FLOOR PL 24MMX24MM W/BENDING TEMP-STER RAPID RESORBABLE ORBITALFLOOR PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREW