BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-04474

    MDR report key: 3233117 · Received July 18, 2013

    Report

    Report Number
    2520274-2013-04474
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR TWO UNKNOWN SCREWS. 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 CAME IN FOR RIB FIXATION ON (B)(6) 2013. POST-OPERATIVE X-RAYS SHOWED NO ISSUES. ON (B)(6) 2013, TWO SCREWS WERE SEEN BACKING OUT OF RIB 7. SURGEON OPTED TO ALLOW THE SCREWS TO REMAIN IN THE PATIENT WITHOUT A SCHEDULED REMOVAL PLANNED. NO ISSUES WERE REPORTED WITH THE PLATE THAT THE SCREWS WERE ATTACHED TO. THIS REPORT IS FOR TWO UNKNOWN SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336106 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR