BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW LOCKING

    MDR report key: 2945858 · Received February 6, 2013

    Report

    Report Number
    2520274-2013-00786
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A CONDYLAR PLATE, 4 LOCKING SCREWS AND 6 PROXIMAL SCREWS FOR A DISTAL FEMUR FRACTURE. THE PATIENT RETURNED TO THE SURGEON FOR A FOLLOW-UP EXAM WHERE X-RAYS WERE TAKEN. X-RAYS REVEALED 4 DISTAL SCREWS BACKED OUT AND THE CONDYLAR PLATE MAY HAVE MIGRATED. THE REMAINING 6 PROXIMAL SCREWS DID NOT APPEAR TO HAVE BACKED OUT. ON (B)(6) 2013, THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF HARDWARE AND REVISION. THIS IS 5 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50776 UNK - SCREW LOCKING LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR