BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP(TM) DISTAL FEMUR PLATE 5 HOLES/156MM-LEFT

    MDR report key: 3960733 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12820
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE: DEVICE WAS NOT EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE AND SCREWS HAD IMPLANTED ON (B)(6), 2012. THE REMOVAL OPERATION WAS PERFORMED ON (B)(6), 2014. THE SCREWS WHICH HAD BEEN IMPLANTED IN THE PROXIMAL SCREW HOLES WERE REMOVED WITH THE SCREWDRIVER WITHOUT ANY PROBLEM. THEN THE SURGEON TRIED TO REMOVE THE SCREWS IN THE DISTAL SCREW HOLES WITH THE SCREWDRIVER ALSO, BUT THE RECESS OF THE SCREWS WERE DAMAGED, SO THE SURGEON USED THE EXTRACTION SCREWS, BUT STILL WASN¿T ABLE TO REMOVE THEM. THE SURGEON DECIDED TO LEAVE THE PLATE AND SCREWS IN THE PATIENT AND COMPLETED THE OPERATION WITH A DELAY OF TEN MINUTES. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438136 LCP(TM) DISTAL FEMUR PLATE 5 HOLES/156MM-LEFT PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention