BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.3MM CANNULATED CONICAL SCREW75MM

    MDR report key: 2901479 · Received January 8, 2013

    Report

    Report Number
    1719045-2012-01263
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    November 7, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS FILE FAILED SUBMISSION FOR (B)(4) 2012 AND THE MEDWATCH WAS CLOSED. THE MEDWATCH WAS REOPENED, PHONE NUMBER CORRECTED, AND IS BEING RESUBMITTED. DEVICE WAS USED FOR TREATMENT. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTED AS (B)(6) 2012, HOWEVER, SHOULD BE (B)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED ON (B)(6) 2011, ORIF RIGHT DISTAL FEMUR: WITH PLATES AND SCREWS. PATIENT RETURNED TO A DIFFERENT SURGEON AND IT WAS DISCOVERED THERE WAS A NON-UNION, DATE UNKNOWN (PATIENT EXPERIENCED DELAYED UNION COMPLEX, R PERIPROSTHETIC FEMUR). ON (B)(6) 2012, ONE CORTICAL COMPRESSION SCREW WAS REMOVED AND THE MOST DISTAL LOCKING SCREW, CLOSEST TO THE FRACTURE WAS REMOVED. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2012, HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO 12 HOLE 95° ANGLE PLATE. ON (B)(6) 2012, THE HOSPITAL CONTACT PROVIDED THE INTRAOPERATIVE REPORT WHICH LISTED ALL THE DEVICES IMPLANTED IN THE PATIENT. THIS REPORT IS TO DOCUMENT THE 7.3MM CANNULATED CONICAL SCREW, WHICH WOULD MAKE THIS REPORT 11 OF 11 FOR THE SAME EVENT. MFR NUMBERS: 2520274-2012-01458; 5250274-2012-01459; 2520274-2012-01462; 1719045-2012-01079; 1719045-2012-01080; 1719045-2012-01081; 1719045-2012-01082; 1719045-2012-01083; 1719045-2012-01084; 1719045-2012-01085; 1719045-2012-01263.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8868 7.3MM CANNULATED CONICAL SCREW75MM 7.3MM CANNULATED CONICAL SCREW75MM HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 7.3MM CANNULATED CONICAL SCREW75MM