BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1212653 · Received October 24, 2008

    Report

    Report Number
    3034525-2008-00018
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 11, 2006
    Report Date
    November 6, 2006
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL# INV-084-IMP-079-100380 OR INV-115-IMP-079-100380. LOT# INV-084-IMP-079-100380 OR INV-115-IMP-079-100380. D6: IF IMPLANTED, GIVEN DATE: UNKNOWN. DEVICE MANUFACTURE DATE: 08/2002 OR 12/2003.

    Description of Event or Problem · 1

    I.M. NAIL BROKE AT SOME UNKNOWN POINT POST SURGERY AND REQUIRED ADDITIONAL SURGERY TO REPAIR. ADDITIONAL INFORMATION WAS REQUIRED FROM THE HOSPITAL, BUT NONE WAS RECEIVED. NO INDICATION OF PRODUCT DEFECT, CAUSE APPEARS TO BE NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I.M. NAIL STANDARD I.M. NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) 100380

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R