BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE

    MDR report key: 2871343 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01344
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING THE REMOVAL OF A TIBIAL NAIL AND HARDWARE (IMPLANTED (B)(6) 2012) DUE TO UNSPECIFIED INFECTION (EXPLANTED (B)(6) 2012). IT WAS REPORTED THAT THE TIBIA WAS HEALED, THE FRACTURE STABLE. THIS IS REPORT # 1 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE TIBAL NAIL HSB SYNTHES MONUMENT 5470019

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention