BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP-DF 4.5/5 R 9HO L236 SST

    MDR report key: 3241519 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04402
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K062564
    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. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATIONS. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE WEN CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO LOW 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 IMPLANT 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. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SURGEON APPLIED THE LOCKING COMPRESSION PLATE (LCP-DF) TO HIS PATIENT FOR A SPIRAL DISTAL FEMORAL FRACTURE 6 MONTHS PRIOR TO THE REPORT. HE FELT THAT THE FRACTURE WAS HEALING WELL, BUT THEN THE PATIENT RETURNED WITH A RETURN OF THE FRACTURE AND A BROKEN PLATE. THE SURGEON USED LAG SCREWS TO COMPRESS THE FRACTURE AND THEN APPLIED THE PLATE AS A PROTECTION PLATE. THE PLATE HAD BROKEN AT THE EXACT POINT OF A LAG SCREW PASSING THROUGH THE PLATE. IN THE INITIAL SURGERY THIS LAG SCREW WAS ORIGINALLY PLACED BEFORE THE APPLICATION OF THE PLATE, BUT THEN REMOVED AND REINSERTED THROUGH THE PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340974 LCP-DF 4.5/5 R 9HO L236 SST HRS SYNTHES GMBH 7601286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention