BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03309

    MDR report key: 3162240 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03309
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 4.5MM LCP CURVED CONDYLAR PLATE, SCREWS AND CABLES CONSTRUCT ON AN UNKNOWN DATE. PATIENT DEVELOPED AN INFECTION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR FIVE (5) UNKNOWN LOCKING SCREWS. THIS IS 4 OF 6 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262106 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention