BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR

    MDR report key: 17240158 · Received June 29, 2023

    Report

    Report Number
    MW5119035
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    November 4, 2022
    Report Date
    June 27, 2023
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RIGHT L2, L3, L4 LAMINOTOMIES PERFORMED ON (B)(6) 2022 . ON (B)(6) 2022, PATIENT EXPERIENCED A SURGICAL WOUND DEHISCENCE AND INFECTION. OUTPATIENT CULTURES REVEALED MSSA(METICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS). ON (B)(6) 2022 PATIENT RETURNED TO THE OPERATING ROOM FOR WOUND DEBRIDEMENT, DURAPLASTY AND CLOSURE OF WOUND DEHISCENCE. PATIENT STARTED ON IV(INTRAVENOUS) CEFTRIAXONE FOR 6 WEEKS FROM (B)(6) 2022. MEDTRONIC DUREPAIR CATALOG NUMBER 62111, LOT 2110019 IMPLANTED. SUBMITTING THIS REPORT DUE TO RECEIPT ON JUNE 20, 2023 OF THE MEDTRONIC DUREPAIR RECALL. THIS MEDTRONIC RECALL NOTICE STATES THAT THE CATALOG NUMBER IMPLANTED IN THIS PATIENT HAD ENDOTOXIN LEVELS THAT WERE OUT OF SPECIFICATION. IT ALSO STATES TO MONITOR FOR SYMPTOMS OF INFLAMMATION SUCH AS FEVER, FLUID COLLECTION, CSF(CEREBRAL SPINAL FLUID) DRAINAGE, AND MENINGISMUS. AS THE PATIENT HAD WOUND DEHISCENCE, AN INFECTION AND A PROTRACTED HEALING PERIOD WITH UNCERTAINTY AS TO IF THE OUT OF SPECIFICATION ENDOTOXIN LEVELS FROM THE RECALLED MEDTRONIC DUREPAIR DEVICE WERE A CONTRIBUTORY FACTOR, WE ARE SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207767 DUREPAIR DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY 2110019

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Hospitalization| O| R