BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2895883 · Received January 3, 2013

    Report

    Report Number
    2520274-2013-00079
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 SUFFERED FROM A BOTH BONE FOREARM FRACTURE (BBFF) ON AN UNKNOWN DATE IN 2008 OR 2009. AT THIS TIME, PATIENT WAS IMPLANTED WITH A 3.5 LCP 6-HOLE PLATE, TWO 1/3 TUBULAR LCP PLATES, AND SCREW CONSTRUCT. ON AN UNKNOWN DATE, PATIENT FELL AND REINJURED THE BBFF. PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. SURGEON REMOVED ALL THE HARDWARE FROM THE RADIUS AND THE ULNA AND REDUCED THE FRACTURE. PATIENT WAS REVISED WITH A 3.5 LCP 12-HOLE PLATE ON RADIUS AND A LCP RECON PLATE ON ULNA. NO FURTHER INFORMATION ON THE RECOVERY OR ANTICIPATED TREATMENT WAS AVAILABLE AT THIS TIME. THIS IS 10 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3654 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PLATE, TUBULAR PLATES, SCREWS