BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE

    MDR report key: 2964229 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00993
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH 6-HOLE ANTEROLATERAL PLATE AND UNKNOWN NUMBER OF SCREWS FOR RIGHT DISTAL TIBIA FRACTURE. SURGEON STATES THE CONTOUR OF THE PLATE WAS NOT PERFECT. CONSULTANT INDICATES THE PATIENT ANATOMY PREVENTED PLATE FROM FITTING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS FROM LCP ANKLE TRAUMA SYSTEM MPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69015 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1