BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

    MDR report key: 4200248 · Received October 24, 2014

    Report

    Report Number
    0001032347-2014-00389
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 23, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 1 OF 3.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A REVISION LESS THAN ONE (1) MONTH POST-OP DUE TO INFECTION. THE DISTRIBUTOR STATED THE FIRST SURGERY WAS PERFORMED ON (B)(6) 2014. ON (B)(6) 2014 SWELLING DUE TO INFECTION WAS OBSERVED. THE DISTRIBUTOR REPORTED THE PLATES AND SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679799 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS LACTO SCR 1.5X4MM 1.5 SYS 2PK NHB BIOMET MICROFIXATION N/A 765550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R