BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04657

    MDR report key: 3251210 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04657
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 6 UNKNOWN LOCKING SCREWS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PLATE REMOVAL. IT WAS A BONE GRAFTED NON-UNION. A NEW PLATE WAS IMPLANTED. THE PATIENT HAD DELAYED HEALING WITH DECREASED ROM. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353013 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention