BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURA NO-REACT DURAL SUBSTITUTE 6CM X 10 CM

    MDR report key: 890048 · Received July 26, 2007

    Report

    Report Number
    3003418325-2007-00007
    Event Type
    Injury
    Date Received
    July 26, 2007
    Date of Event
    March 14, 2006
    Report Date
    June 1, 2007
    Manufacturer
    SHELHIGH, INC
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORPORATION IS FILING A DISTRIBUTOR REPORT BASED UPON INFORMATION PROVIDED BY THE USER FACILITY. CORRESPONDENCE SHOULD BE SENT TO: DISTRIBUTOR: ATTN: CORPORATE COMPLAINT COORDINATOR. THE CULTURE REPORTS FROM THE HOSPITAL ON THE REMOVED ENDURA NO-REACT DURAL SUBSTITUTE DEMONSTRATED NO GROWTH OF ORGANISMS. THE NAMSA STERILITY REPORTS FOR THE LOTS IN QUESTION SHOWED THAT THE RELEASE SAMPLES WERE NEGATIVE FOR GROWTH.

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES INITIATED A RECALL AS A DISTRIBUTOR OF THE ENDURA NO-REACT DURAL SUBSTITUTE MANUFACTURED BY SHELHIGH, INC. THIS WAS IN RESPONSE TO FDA'S PUBLIC HEALTH NOTIFICATION AND NOTICE TO THE MANUFACTURER, SHELHIGH, INC., REQUESTING A RECALL OF ALL THEIR PRODUCTS INCLUDING THE ENDURA NO-REACT DURAL SUBSTITUTE. AS PART OF THIS FDA COMPLIANCE INITIATIVE, WE REVIEWED ALL COMPLAINT FILES ON ENDURA NO-REACT DURAL SUBSTITUTE. IN REVIEWING THE COMPLAINT DATABASES AND THE FDA MAUDE DATABASE INTEGRA WAS UNABLE TO CONFIRM THAT THE ENCLOSED MDR WAS SUBMITTED TO THE FDA BY THE MANUFACTURER SHELHIGH, INC. THEREFORE, WE ARE SUBSEQUENTLY SUBMITTING THIS MDR AS A DISTRIBUTOR. THE NEUROSPECIALIST REPORTED THE FOLLOWING INCIDENT ON BEHALF OF THE USER FACILITY. THE SURGEON PERFORMED BRAIN SURGERY ON THE PATIENT IN 2006. ENDURA NO-REACT DURAL SUBSTITUTE MANUFACTURED BY SHELHIGH, INC. WAS USED. THE HOSPITAL'S STANDARD PROCEDURE REQUIRES TO SAMPLE A PIECE OF THE DURAL SUBSTITUTE FOR MICROTESTING. THE USER FACILITY CUT A SAMPLE FROM THE DEVICE PIECE THAT WAS ON THE "STERILE FIELD" AND SUBSEQUENTLY CULTURED A STRAIN OF PSEUDOMONAS AERUGINOSA. THE USER FACILITY INFECTION CONTROL SPECIALIST MADE THE DECISION THAT THE ENDURA NO-REACT DURAL SUBSTITUTE SHOULD BE REMOVED. TWO DAYS LATER, A PROCEDURE WAS PERFORMED TO REMOVE THE ENDURA NO-REACT DURAL SUBSTITUTE AND REPLACE WITH ANOTHER DURAL SUBSTITUTE. PER THE SURGEON, THERE "WASN'T ANY INFECTION AND THE SITE WAS CLEAN". THE SURGEON SUSPECTED THAT THE EARLIER TEST RESULT MIGHT BE A LAB ERROR. THE ENDURA NO-REACT DURAL SUBSTITUTE REMOVED FROM THE PATIENT WAS SUBMITTED BY THE USER FACILITY FOR CULTURE. SIX DAYS LATER, THE MICROBIOLOGY CULTURE REPORT ON THE ENDURA NO-REACT DURAL SUBSTITUTE REMOVED FROM THE PATIENT SHOWED NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURA NO-REACT DURAL SUBSTITUTE 6CM X 10 CM NONE GXQ SHELHIGH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization