BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD CURV 14HO L265 SST

    MDR report key: 3211200 · Received July 8, 2013

    Report

    Report Number
    8030965-2013-04241
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    November 13, 2012
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT THE PLATES ARE MADE OF STAINLESS STEEL. THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEETS OF THE SUPPLIER AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE DIMENSIONS OF THE INVESTIGATED PLATES WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, WE CAN CONCLUDE THAT THE IMPLANTS WERE SUBJECTED TO DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE PLATES. THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD /FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE EXPLANTED ON AN UNKNOWN DATE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: TWO PLATES BROKE IN SITU. THERE WAS A CAR ACCIDENT IN 2010, LEAVING FRACTURES OF THE TWO LEGS, ONE CONSOLIDATION. THERE WAS ALSO A NAIL FAILURE. THERE WAS NO INFECTION. AN XRAY WAS TAKEN ON (B)(6) 2012 SHOWING THE FIRST PLATE WAS INTACT. AN XRAY ON (B)(6) 2012, SHOWED RUPTURE OF THE PLATE. ON (B)(6) 2012, A NEW PLATE WAS PUT IN. ON (B)(6) 2013 THE SECOND PLATE RUPTURED. THIS COMPLAINT IS FOR THE FIRST PLATE. AFTER THE CAR ACCIDENT IN 2010, A NAIL, NOT A SYNTHES PRODUCT WAS INSERTED, BUT DUE TO A NON UNION THE NAIL WAS REPLACED WITH OUR PLATE ON THE (B)(6) 2012. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310459 LCP 4.5/5 BROAD CURV 14HO L265 SST KTT SYNTHES GMBH 2702318

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention