BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD CURV 12HO L229 TI

    MDR report key: 2922819 · Received January 18, 2013

    Report

    Report Number
    8030965-2013-00173
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WAS FOUND. WE HAVE FORWARDED THE COMPLAINED PLATE TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION, HERE THE FEEDBACK, THE PLATE IS INDEED BROKEN IN THE MIDDLE AND TROUGH A HOLE OF THE PLATE. WITH AN IMPLANTATION IN (B)(6) 2012 AND A REOPERATION IN (B)(6) 2012 THE NORMAL HEALING TIME IS CLEARLY EXCEEDED, NON-UNION, WE ASSUME: A FATIGUE FAILURE OF THE IMPLANT HAS OCCURRED. THE MANUFACTURING DOCUMENTS DO SHOW CONFORMITY TO THE SPECIFICATIONS. THE PLATE MET FULLY OUR SPECIFICATIONS AT THE TIME WHEN IT WAS DISTRIBUTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. IMPLANT DATE REPORTED AS (B)(6) 2012. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    HOSPITAL IN (B)(6) REPORTED A PATIENT WITH A FEMORAL NONUNION DUE TO PSEUDOARTHROSIS. THE PATIENT WAS INITIALLY IMPLANTED WITH AN LCP PLATE AND CABLE FOR OSTEOSYNTHESIS OF A FEMORAL STEM LOWER BONE FRACTURE IN (B)(6) 2012. POST IMPLANT, THE PATIENT COMPLAINED OF PAIN AND EXAMINATION NOTED THE PLATE WAS BROKEN. THE PATIENT WAS RETURNED TO THE O.R ON (B)(6) 2012 FOR REMOVAL OF THE HARDWARE AND REVISION TO AN LCP DF PLATE AND CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27537 LCP 4.5/5 BROAD CURV 12HO L229 TI PLATE HRS SYNTHES GMBH 2808021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS