BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP-DF 4.5/5 R 13HO L316 TAN

    MDR report key: 2870456 · Received December 12, 2012

    Report

    Report Number
    8030965-2012-01545
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 13, 2012
    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

    IN THE MACROSCOPIC EXAMINATION, THE PLATE EXHIBITS PARTLY MASSIVE MECHANICAL DAMAGES. THESE CAME ABOUT WITH HIGH PROBABILITY WHEN THE PLATE WAS EXPLANTED. A MICRO-METALLOGRAPHIC INSPECTION OF THE RAW MATERIALS USED REVEALED NO MATERIAL DEFECTS. THE MICROSTRUCTURE AND THE HARDNESS MEASURED CONFORM TO THE SPECIFICATIONS. NO IRREGULARITIES, INCLUSIONS OF NON-METALLIC MATERIALS, ETC., OR SIGNS OF EMBRITTLEMENT WERE FOUND. THE IMPLANT COMPLAINED OF CAN BE CLEARLY ALLOCATED TO ITS RAW MATERIAL WITH THE AID OF THE ARTICLE NUMBER AND THE LOT NUMBER. THE RAW MATERIAL INCOMING GOODS INSPECTION TO WHICH EVERY RAW MATERIAL LOT IS SUBJECTED ENSURES THAT ALL IMPLANTS ARE MANUFACTURED FROM MATERIALS WHICH MEET THE REQUIREMENTS OF THE INTERNATIONAL STANDARDS AND THE AO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS REPORT IS #5 OF 5 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN GERMANY AS FOLLOWS: PATIENT WAS IMPLANTED WITH PLATES AND SCREWS ON (B)(6) 2012. IT WAS REPORTED FOUR (4) DYNAMIC LOCKING SCREWS WERE BROKEN. PATIENTS FRACTURE WAS NOT HEALED. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE IMPLANT REMOVAL WAS SUCCESSFUL. THIS IS 5 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP-DF 4.5/5 R 13HO L316 TAN PLATE HRS SYNTHES GMBH 7952203

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCREWS