BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP DIST-TIBPL3.5 ANTERO-LAT R 13HO L184

    MDR report key: 3091470 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02108
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS FAR AS VISIBLE ON THE X-RAY IMAGES THE PLATE WAS FIXED WITH THIRTEEN SCREWS AND ONE ADDITIONAL SCREW WAS SET NEAR THE PLATE. THE BREAKAGE OF THE INVESTIGATED LCP WAS DUE TO DYNAMIC BENDING WHICH LED TO THE MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE INVESTIGATED IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. THIS COMPLAINT IS INVALID. ONE OF THE DATES OF THE X-RAYS WAS REPORTED INCORRECTLY ON THE INITIAL REPORT. IT HAS BEEN CORRECTED HEREIN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PLATE BROKE AT A SCREW HOLE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH THE LCP ALDTP AND LAG SCREW FOR A RIGHT TIBIA SHAFT FRACTURE. A PTB BRACE WAS APPLIED ON (B)(6) 2012. ON (B)(6) 2013, THE SURGEON FOUND METAL BROKEN THROUGH X-RAY. THE SURGEON REMOVED THE BROKEN PLATE AND INSERTED A NAIL ON (B)(6) 2013. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193955 LCP DIST-TIBPL3.5 ANTERO-LAT R 13HO L184 KTT SYNTHES GMBH 7622577

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention