BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 36MM

    MDR report key: 2850010 · Received November 29, 2012

    Report

    Report Number
    1719045-2012-01208
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DUE TO THE TYPE AND EXTENT OF DAMAGED INCURRED, AND ALSO BECAUSE NO LOT NUMBER WAS PROVIDED, A FINITE EVALUATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH DHS CONSTRUCT ON (B)(6) 2012. THE SCREW HEADS ON THE SCREW POPPED OFF AND THE PLATE LEVERED OFF OF THE FEMUR LATERALLY. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH A 6 HOLE 145 DEGREE DHS CONSTRUCT AND PATIENT WAS AUGMENTED WITH RIA GRAFT. THIS IS 4 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW SELF-TAPPING 36MM CORTEX SCREW HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention PLATE, LAG SCREW, SCREWS