BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP-DF 4.5/5 LE 13HO L316 SST

    MDR report key: 2971502 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-00390
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PLATE AND SCREWS FOR AN EXTRA ARTICULAR DISTAL FEMUR FRACTURE DUE TO A GUN SHOT WOUND ON (B)(6) 2012. THE PATIENT DID WEIGHT BEARING FULLY IMMEDIATELY AFTER SURGERY. IT WAS NOTED, ACTUALLY RUNNING, PATIENT STILL IS PSYCHOTIC. AN X-RAY (B)(6) 2013 SHOWED THE PLATE WAS BENT AT THE FRACTURE LEVEL. PATIENT WAS RETURNED TO OR ON (B)(6) 2013 FOR RE OPERATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75667 LCP-DF 4.5/5 LE 13HO L316 SST LCP-DF 4.5/5 LE 13HOLE HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention