BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01788

    MDR report key: 3032615 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-01788
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 8-HOLE PLATE AND SIX SCREWS ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PLATE WAS IMPINGING UPON PRONATION. PATIENT RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. THE ORIGINAL 8-HOLE PLATE AND SIX SCREWS WERE REMOVED AND REPLACED WITH A 9-HOLE PLATE AND AN UNKNOWN NUMBER OF SCREWS IN A NEW LOCATION. THE SURGERY REPORTEDLY WENT WELL WITHOUT ANY ISSUES. THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW. THIS IS 6 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136649 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention