BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2891832 · Received December 31, 2012

    Report

    Report Number
    2520274-2012-04398
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE 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 4.5MM LCP PROXIMAL TIBIA PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. X-RAYS TAKEN ON AN UNKNOWN DATE REVEALED NON-UNION AND POSSIBLE INFECTION. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. ONCE IT IS VERIFIED THAT NO INFECTION REMAINS, SURGEON WILL RETURN PATIENT TO THE OPERATING ROOM ON A FUTURE DATE FOR A TOTAL KNEE REPLACEMENT. THIS IS 4 OF 8 REPORTS FOR THE SAME EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PLATE, SCREWS