BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø4.5 L26 TI

    MDR report key: 3133067 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02369
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K974537
    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. IMPLANT OCCURRED APPROXIMATELY THREE YEARS PRIOR TO EVENT. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED ON (B)(6) 2013. THE REPORT INDICATES THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEETS OF THE SUPPLIERS AND THE MANUFACTURING DOCUMENTS OF THE PRODUCER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIALS ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE WE ASSUME THAT THE IMPLANTS WERE SUBJECTED TO A MODERATE DYNAMIC LOADS. CONSTANTLY ALTERNATING LOADS OVER A LONG PERIOD OF TIME LED TO THE FATIGUE OF MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE IMPLANTS. THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED DO THE MATERIAL OVERLOAD / FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. CORRECTED COMPLAINT NUMBER FROM (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PROCEDURE TOOK PLACE APPROXIMATELY 3 YEARS PRIOR TO (B)(6) 2013 TO TREAT A MIDSHAFT HUMERAL FRACTURE. THE PLATE BROKE ALONG WITH ONE SCREW. THE SURGEON DECIDED TO REVISE THE CASE. THE SCREWS AND BROKEN PLATE WERE REMOVED. THE PATIENT¿S NON-UNITED FRACTURE WAS TREATED WITH A MULTILOC HUMERAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PROCEDURE TOOK PLACE APPROXIMATELY 3 YEARS PRIOR TO (B)(6) 2013 TO TREAT A MIDSHAFT HUMERAL FRACTURE. THE PLATE BROKE ALONG WITH ONE SCREW. THE SURGEON DECIDED TO REVISE THE CASE. THE SCREWS AND BROKEN PLATE WERE REMOVED. THE PATIENT'S NON-UNITED FRACTURE WAS TREATED WITH A MULTILOC HUMERAL NAIL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236163 CORTSCR Ø4.5 L26 TI KTT SYNTHES GMBH 3158361

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention