BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM F/IM NAIL-STER

    MDR report key: 2870465 · Received December 12, 2012

    Report

    Report Number
    1719045-2012-01341
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. 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 TIBIAL NAIL (B)(6) 2012 FOR TIBIAL SHAFT FRACTURE. PATIENT RETURNED TO O.R. WITH OPERATIVE SITE SEPTIC ARTHRITIS INFECTION ON (B)(6) 2012. SURGEON PERFORMED AN ARTHROSCOPIC LAVAGE AS TREATMENT PLAN. NO HARDWARE WAS REMOVED. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 30MM F/IM NAIL-STER LOCKING SCREW HWC SYNTHES MONUMENT 5790131

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention NAIL, SCREW