BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR

    MDR report key: 17239259 · Received June 29, 2023

    Report

    Report Number
    MW5119017
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    March 1, 2023
    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

    CRANIOTOMY PERFORMED ON (B)(6) 2023 USING MEDTRONIC DUREPAIR DEVICE, 62110, LOT 2202031 THAT HAS NOW BEEN RECALLED BY THE MFG. ON (B)(6) 2023 REPEAT CT DEMONSTRATED LEFT SUBDURAL CSF FLUID COLLECTION UNDERNEATH THE BONE FLAP WITH SIGNIFICANT MASS EFFECT. PATIENT ALSO NOTING ONGOING HEADACHE. THE PATIENT RETURNED TO THE OR ON (B)(6) 2023 FOR EXPLORATION OF CRANIOTOMY, EVACUATION OF SUBDURAL FLUID COLLECTION AND DRAIN PLACEMENT. DURING SURGERY IT WAS NOTED THAT THERE WAS A HOLE APPROXIMATELY 2.5 CM IN SIZE THROUGH THE CENTER OF THE MEDTRONIC DUREPAIR GRAFT; CATALOG 62110, LOT 2202031 THAT HAD BEEN PLACED IN THE (B)(6) 2023 SURGERY AND THE GRAFT HAD BROKEN DOWN. THIS GRAFT WAS REMOVED AND MEDTRONIC DUREPAIR, MODEL 62110, LOT 220607 WAS IMPLANTED IN THIS (B)(6) 2023 PROCEDURE. ON (B)(6) 2023, CT OF THE HEAD SHOWED POSTSURGICAL CHANGES AND AN INTERVAL DEVELOPMENT OF SMALL SOFT TISSUE FLUID COLLECTION ALONG THE ANTERIOR CRANIOTOMY SITE MEASURING 5 MM IN DEPTH. SUBMITTING THIS REPORT DUE TO RECEIPT ON JUNE 20, 2023 OF THE MEDTRONIC DUREPAIR RECALL. THIS MEDTRONIC RECALL NOTICE STATES THAT THE CATALOG NUMBER (62110) AND THE TWO IDENTIFIED LOTS THAT WERE 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 DRAINAGE, AND MENINGISMUS. AS THE PATIENT EXPERIENCED CSF FLUID COLLECTION WE ARE SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION. REFERENCE REPORT: #MW5119016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039631 DUREPAIR DURA SUBSTITUE GXQ MEDTRONIC NEUROSURGERY 62110 2206007

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other| R| H