BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3215508 · Received July 10, 2013

    Report

    Report Number
    8030965-2013-04227
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    December 16, 2012
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RECEIVED 6/18/2013 NOT 6/24/2013.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS (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 IMPLANT. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THERE WAS FATIGUE OF THE PLATE AFTER 11 WEEKS. ADDITIONAL ITEMS ALL INTACT: 2 X 204.016, LOT 8076893, 1 X LOT 8170822, 1 X 204.020, LOT 7929206, 1 X 212.105, AND LOT 8073473. THE PATIENT SUFFERED FROM AN ANKLE FRACTURE AND DISLOCATION. OSTEOSYNTHESIS THIRD TUBULAR PLATE AND LIGAMENT REPAIR OF THE CAPSULE WAS PERFORMED. MATERIAL WAS RECEIVED ON (B)(4) 2013 AND WAS FORWARDED FOR INVESTIGATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318188 LCP 1/3-TUB-PL 3.5 6HO L76 SST HRS SYNTHES GMBH 7917586

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention