BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 10308067 · Received July 22, 2020

    Report

    Report Number
    2021898-2020-00201
    Event Type
    Injury
    Date Received
    July 22, 2020
    Report Date
    September 30, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NONE OF THE COMPLICATIONS IN THE ARTICLE ARE DIRECTLY RELATED TO THE MANUFACTURER'S DE VICES/PRODUCTS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MOHAMEDKAZIM M. ALWANI, MOHAMAD Z. SALTAGI, MARGARET E. MACPHAIL, RICK F. NELSON. MIDDLE CRANIAL FOSSA REPAIR OF TEMPORAL BONE SPONTANEOUS CSF LEAKS WITH HYDROXYAPATITE BONE CEMENT. LARYNGOSCOPE 00 (2020). DOI: 10.1002/LARY.28761 OBJECTIVES: TO DETERMINE THE SAFETY AND EFFECTIVENESS OF THE MIDDLE CRANIAL FOSSA (MCF) APPROACH IN REPAIRING SPONTANEOUS CEREBROSPINAL FLUID (SCSF) LEAKS. STUDY DESIGN: RETROSPECTIVE COHORT STUDY. METHODS: PATIENT WITH SCSF LEAKS REPAIRED BY MCF APPROACH BETWEEN JANUARY 1, 2014 AND AUGUST 31, 2019 WERE INCLUDED. DEMOGRAPHIC INFORMATION, CLINICAL AND SURGICAL FINDINGS, AND POSTOPERATIVE OUTCOMES WERE RECORDED. RESULTS: THECOHORT (N = 45) INCLUDED 24 TEGMEN REPAIRS BY MULTILAYER RECONSTRUCTION USING HYDROXYAPATITE CEMENT AND 21 CASES OF MULTILAYER REPAIR WITHOUT HYDROXYAPATITE CEMENT. TEN MCF REPAIRS WERE PERFORMED ON PATIENTS =65 YEARS OLD. TWENTY (53%) EARS HAD MULTIPLE TEGMEN DEFECTS (RANGE, 1¿9 TEGMEN DEFECTS) AND 78% OF PATIENTS HAD =1 ENCEPHALOCELES. ALL SCSF LEAKS WERE RESOLVED WITH ONE SURGICAL INTERVENTION. THERE WERE NO MAJOR INTRACRANIAL COMPLICATIONS. TRANSIENT EXPRESSIVE APHASIA OCCURRED IN 2 PATIENTS. MEDICAL COMPLICATIONS OCCURRED IN FOUR PATIENTS. THERE WERE NO SHORT-TERM POSTOPERATIVE CSF LEAKS WITH BONE CEMENT RECONSTRUCTION AND TWO POSTOPERATIVE LEAKS WITHOUT BONE CEMENT. ONE RESOLVED WITH LUMBAR DRAIN (LD) AND THE OTHER RESOLVED WITHOUT TREATMENT. THE AVERAGE (SD) LENGTH OF STAY (LOS) WITH BONE CEMENT WAS SHORTER THAN IN PATIENTS WITHOUT BONE CEMENT (2.54 [0.83] DAYS VS. 3.52 [1.99] DAYS, P <(><<)> .05). THERE HAVE BEEN NO LONG-TERM CSF LEAK RECURRENCES WITH AN AVERAGE (SD) FOLLOW-UP OF 13.5 (12.9) MONTHS (RANGE 0.25¿46 MONTHS). CONCLUSIONS: MCF APPROACH FOR SCSF REPAIRS DEMONSTRATE EFFICACIOUS OUTCOMES, PARTICULARLY WITH TEGMEN RECONSTRUCTION USING HYDROXYAPATITE CEMENT. THE APPROACH EXHIBITED NO SERIOUS ADVERSE EVENTS AND FEW COMPLICATIONS REQUIRING INTERVENTION. THEREFORE, MCF IS A SAFE AND EFFECTIVE APPROACH TO RESOLVE SCSF LEAKS. REPORTED EVENTS. - A (B)(6) FEMALE PRESENTED WITH EARLY POSTOPERATIVE CSF LEAK. THE PATIENT DID NOT HAVE BONE CEMENT RECONSTRUCTION. THE PATIENT HAD POSTOPERATIVE OTORRHEA THAT RESOLVED WITH LD PLACEMENT FOR 5 DAYS. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771279 DUREPAIR DURA SUBSTITUTE DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN-D UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R