BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE

    MDR report key: 3212885 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04150
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 25, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES USA
    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

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

    Additional Manufacturer Narrative · 1

    PART RECEIVED. AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE LOCKING COMPRESSION PLATE (LCP) RECONSTRUCTION PLATE WAS IMPLANTED BECAUSE OF CLAVICLE SHAFT FRACTURE. AS FAR AS VISIBLE ON THE X-RAY IMAGES, THE PLATE WAS FIXED WITH FIVE SCREWS. IN ADDITION THE BONE FRACTURE WAS STABILIZED WITH TWO TENSION SCREWS. ACCORDING TO THE DEVICE REPORT THE PATIENT FELT A PAIN AFTER HE HAD A FIGHT. THE REVISION SURGERY TO REMOVE THE BROKEN IMPLANT WAS PERFORMED ON THE SAME DAY. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO MODERATE DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE LCP RECONSTRUCTION PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD AND FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT WAS TREATED FOR A CLAVICLE SHAFT FRACTURE ON AN UNKNOWN DATE. THE PRIMARY FIXATION WAS VERY GOOD AND THE SURGEON RESTRICTED THE MOTION BY 90 DEGREES. THE PATIENT FELT A LARGE PAIN AT THE CLAVICLE AFTER A FIGHT, AND VISITED THE HOSPITAL AT (B)(6) 2013. THE SURGEON RECOGNIZED THE PLATE WAS BROKEN THROUGH X-RAY. THE SURGEON BELIEVED THE CAUSE MIGHT BE ON THE PATIENT, BUT SAID THE PLATE SHOULD NOT BE BROKEN BY SOME STRESS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312615 LCP RECOPL 3.5 STRAIGHT W/COMBINED HOLE KTT SYNTHES USA 8087777

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention