BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW LOCKING

    MDR report key: 2962952 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00960
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. IMPLANTED APPROXIMATELY (B)(6) 2011. 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 IM NAIL FOR A TIBIAL SHAFT FRACTURE APPROXIMATELY (B)(6) 2011, EIGHTEEN MONTHS AGO. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, ALL HARDWARE WAS REMOVED DUE TO SUSPECTED UNSPECIFIED INFECTION. PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER INFORMATION WAS AVAILABLE. THIS IS 5 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68696 SCREW LOCKING HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention