BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2821312 · Received October 12, 2012

    Report

    Report Number
    2520274-2012-02264
    Event Type
    Injury
    Date Received
    October 12, 2012
    Report Date
    September 16, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT. IMPLANT DATE: APPROXIMATELY (B)(6) 2012. EXPLANT DATE: (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT WAS INITIALLY IMPLANTED WITH A 10 HOLE LOCKING CONDYLAR PLATE ON THE RIGHT LEG FOR AN OPEN DISTAL FEMUR FRACTURE APPROXIMATELY 6 MONTHS PRIOR TO REVISION. THE PATIENT PRESENTED TO THE EXPLANTING SURGEON WITH A VARUS MALUNION WITH NO IMPLANT FAILURE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REVISION WITH A CLOSING WEDGE OSTEOTOMY AND A RETROGRADE NAIL. THIS REPORT IS #8 OF 17 FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PLATE| SCREW