BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM BROAD LCP PLATE 14HO L260 SST

    MDR report key: 2883744 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01652
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    March 28, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS 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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE EXAMINATION OF THE MANUFACTURER DOCUMENTS, TECHNICAL DRAWING AND RAW-MATERIAL INSPECTION CERTIFICATE SHOWED THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES CORRESPOND TO THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH TECHNICAL DRAWINGS OF THE PRODUCER AND AO ASIF SPECIFICATIONS. THE FAILURE WAS DUE TO DOUBLE SIDED DYNAMIC BENDING LOADS WHICH LED TO THE MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES FOR A LARGE NUMBER OF CYCLES. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    RECEIVED DEVICE REPORT FROM SYNTHES (B)(6). A FACILITY IN (B)(6) REPORTED A POST OPERATIVE PLATE BREAKAGE. PATIENT WAS ADMITTED ON (B)(6) 2012 WITH A MIDSHAFT FEMORAL FRACTURE. AN LCP BROAD PLATE WAS USED TO TREAT THE FRACTURE. PATIENT RETURNED ON (B)(6) 2012 WITH A BROKEN PLATE. THE BROKEN PLATE WAS REMOVED ON (B)(6) 2012 AND PATIENT WAS REVISED WITH A CANNULATED FEMORAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM BROAD LCP PLATE 14HO L260 SST 4.5MM BROAD LCP PLATE KTT SYNTHES GMBH 2695720

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCREWS