BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTIM(R) TIBIAL SELF-TAP. CANCELLOUS BONE SCREW

    MDR report key: 1883391 · Received October 26, 2010

    Report

    Report Number
    1043534-2010-00437
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    October 9, 2009
    Report Date
    June 10, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    PMA / PMN Number
    K864626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00430, 00434, 00435, 00436, 00438, 00439. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD SURGERY SITE INFECTION. HOSPITAL CANNOT RULE OUT PRODUCT INVOLVEMENT.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD SURGERY SITE INFECTION. HOSPITAL CANNOT RULE OUT PRODUCT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTIM(R) TIBIAL SELF-TAP. CANCELLOUS BONE SCREW KNEE COMPONENT HWC WRIGHT MEDICAL TECHNOLOGY, INC. 049825290

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization