BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, 8 HOLE STRAIGHT

    MDR report key: 3834372 · Received May 28, 2014

    Report

    Report Number
    0001032347-2014-00169
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT FAILED TO FOLLOW POST-OPERATIVE INSTRUCTIONS AS INDICATED BY THE SURGEON. PATIENT CRAWLED UNDER HOMES WHICH RESULTED IN LOAD BEARING ON THE PLATE. THE PLATE BROKE AND THE PATIENT'S BONE LACERATED THE LUNG. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. PATIENT IS IN LEGAL ACTION WITH THE SURGEON, THEREFORE NO RETURN HAS BEEN APPROVED FOR MANUFACTURER REVIEW. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A REVISION WAS PERFORMED DUE TO THE PLATE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312738 PLATE, 8 HOLE STRAIGHT BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization