BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT R SHA

    MDR report key: 2771916 · Received September 28, 2012

    Report

    Report Number
    3003506883-2012-00290
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    August 26, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K011978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD (DHR) FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED INCIDENT. SUBJECT PRODUCT LOT MET ALL VISUAL AND DIMENSIONAL REQUIREMENTS THROUGHOUT MANUFACTURING AND RELEASE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DIMENSIONS WERE FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO ASIF SPECIFICATIONS. THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEET AND THE MANUFACTURING PAPERS SHOWED THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES WERE IN ACCORDANCE WITH THE INTERNATIONAL STANDARDS ISO 5832 1, ASTM F138 AND AO ASIF SPECIFICATIONS. THE FAILURE WAS DUE TO DYNAMIC BENDING WHICH LED TO OVERLOAD AND MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE INVESTIGATED PLATE HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PT WAS IMPLANTED WITH A LCP PROXIMAL TIBIAL PLATE ON AN UNK DATE. IT WAS DISCOVERED PT HAD A BROKEN PLATE ON AN UNK DATE. REPORTEDLY THE PT WAS DOING DAILY ACTIVATES. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, THE PLATE WAS REMOVED AND THERE WAS REMOVAL OF OSTEOSYNTHESIS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT R SHA LCP PROXIMAL TIBIAL PLATE HRS SYNTHES ELMIRA 6454250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREW| PLATE