BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW, SELF-TAPPING

    MDR report key: 2190416 · Received July 28, 2011

    Report

    Report Number
    2520274-2011-00525
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    March 31, 2010
    Report Date
    June 29, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Description of Event or Problem · 1

    PATIENT WAS TREATED FOR A LEFT OPEN TIBIAL TUBERCLE TRANSFER, OPEN VASTUS MEDIALIS OBLIQUE MUSCLE ADVANCEMENT, LATERAL RELEASE, CHONDROPLASTY OF PATELLA, RELEASE OF SUPRAPATELLAR ADHESIONS, AND PARTIAL MEDIAL MENISECTOMY ON/ABOUT (B)(6) 2009 AND A 4.5MM CORTEX SCREW, SELF-TAPPING WAS IMPLANTED. ON (B)(6) 2010, THE SCREW WAS NOTED TO BE BROKEN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2010 AND THE BROKEN SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW, SELF-TAPPING CORTEX SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention