BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2902088 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00192
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A PLATE AND SEVEN SCREWS ON (B)(6) 2007 DUE TO A GENERAL NOSE FRACTURE, NASAL ORBITAL ETHMOID (NOE). ON AN UNKNOWN DATE THE PATIENT CAME IN FOR A HARDWARE REMOVAL BECAUSE THE PLATE WAS EXPOSED AND COMING THROUGH THE SKIN OF THE NOSE. THE SURGEON EXPLANTED THE PLATE AND SEVEN SCREWS. THE NOSE FRACTURE WAS HEALED AND THE SURGEON DID NOT REPLACE THE EXPLANTED PLATE AND SEVEN SCREWS. NONE OF THE EXPLANTS WERE BROKEN AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS 6 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9445 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention PLATE, SCREWS