BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 1/3-TUB-PL 3.5 6HO L76 TI

    MDR report key: 3191217 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-04088
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K011335
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLATE REPORTED BROKEN FIVE WEEKS AFTER IMPLANT DATE. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. (B)(4). THE DIMENSIONS WERE FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. BASED ON THE STRUCTURE OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO MODERATE DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD AND FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT IN COMBINATION WITH A POSSIBLE INSTABILITY OF THE FRACTURE SITUATION MAY HAVE PLAYED A CERTAIN ROLE TOO. 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 PLATE WAS IMPLANTED ON (B)(6) 2013. PART OF THE PLATE BROKE 5 WEEKS AFTER INSERTION. PATIENT UNDERWENT ANOTHER SURGERY ON (B)(6) 2013 TO REMOVE THE OLD PLATE AND INSERT A NEW PLATE. SIX INTACT SCREWS WERE ALSO REMOVED. NO PART REMAINED IN THE PATIENT, NO FURTHER TREATMENT WAS REQUIRED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291399 LCP 1/3-TUB-PL 3.5 6HO L76 TI HRS SYNTHES GMBH 8214332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention