BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

    MDR report key: 4791870 · Received May 22, 2015

    Report

    Report Number
    0001032347-2015-00224
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 23, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    NHB
    PMA / PMN Number
    PK012409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. 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. FILE THREE OF SIX FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOUR MONTHS AFTER CRANIAL SURGERY, THE AFFECTED AREA WAS RAISED AND THE ARTIFICIAL BONE (NOT BIOMET PRODUCT) WAS CONFIRMED TO BE FLOATING. DURING THE REVISION SURGERY IT WAS IDENTIFIED THE PLATES USED TO FIXATE THE ARTIFICIAL BONE WERE BROKEN AT THE BONE INCISION LINE. ACCORDING TO THE SURGEON'S COMMENT "THE PATIENT HAD EXCESSIVE ACTIVITY AND HIGH BRAIN PRESSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335897 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS BONE SCREW NHB BIOMET MICROFIXATION N/A 235470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R