BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW LOCKING

    MDR report key: 2874621 · Received December 15, 2012

    Report

    Report Number
    2520274-2012-04021
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 IMPLANTED WITH VA 2 COLUMN DISTAL RADIUS PLATE ON UNKNOWN DATE. PATIENT PRESENTED TO SURGEON UNABLE TO MOVE THUMB, DATE UNKNOWN. X-RAYS REVEALED FLEXOR POLLICUS LONGUS TENDON HAD RUPTURED OVER THE IMPLANT. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE AND REPAIR OF TENDON. PATIENT FRACTURE WAS HEALED, PATIENT NOT REVISED TO ANY OTHER HARDWARE. THIS IS 2 OF 9 REPORTS FOR THIS EVENT..

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention PLATE, SCREWS