BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM

    MDR report key: 3500966 · Received December 5, 2013

    Report

    Report Number
    2520274-2013-07577
    Event Type
    Injury
    Date Received
    December 5, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL PRODUCT: KTT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WITH AN ULNA FRACTURE WAS IMPLANTED WITH A 2.7MM LOCKING COMPRESSION PLATE (LCP) ULNA OSTEOTOMY PLATE ON AN UNKNOWN DATE. PATIENT COMPLAINED OF PAINFUL HARDWARE AND REQUESTED HARDWARE REMOVAL. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL. ALL HARDWARE WAS INTACT AND PATIENT HAD HEALED. THIS REPORT IS 2 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630533 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention