BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNALOCK® BLU SYSTEM

    MDR report key: 8228581 · Received January 8, 2019

    Report

    Report Number
    8228581
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    August 8, 2018
    Report Date
    November 2, 2018
    Manufacturer
    BIOMET MICROFIXATION, INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BIOMET TITANIUM PLATES IMPLANTED ORIGINALLY LATE (B)(6) 2018 ON BOTH THE LEFT AND RIGHT CHEST WALL DUE TO HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG) WITH STERILE STERNAL DEHISCENCE WITH DEVELOPMENT OF STERNAL INSTABILITY. THERE WAS NO EVIDENCE OF INFECTION, BUT PATIENT DID REPORT SIGNIFICANT COUGHING IN THE EARLY POST OP PERIOD AS WELL AS RETURNING TO SIGNIFICANT WEIGHT LIFTING POSTOPERATIVELY. SEVERAL WEEKS POSTOP, PATIENT COMPLAINED OF CHEST WALL INSTABILITY AND PAIN AGAIN AND IN (B)(6) 2018, PATIENT RETURNED TO SURGERY FOR REDO BILATERAL PECTORALIS MAJOR MUSCLE ADVANCEMENT FLAPS. THE PLATES WERE OBSERVED BY THE SURGEON AND APPEARED TO BE FRACTURED. BOTH THE PLATES AND SCREWS WERE REMOVED ALONG WITH THE PREVIOUS STERNAL HARDWARE IN ITS ENTIRETY AND REPLACED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO KNOWN HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19396 STERNALOCK® BLU SYSTEM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION, INC 73-2416 LOG2614102

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA