BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFLEX DURAL GRAFT

    MDR report key: 18007629 · Received October 25, 2023

    Report

    Report Number
    3002719998-2023-00020
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 16, 2023
    Report Date
    December 29, 2023
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    GXQ
    PMA / PMN Number
    K132850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GRAFT WAS DISCARDED AT THE FACILITY AND NOT AVAILABLE FOR EVALUATION AT RTI. RTI WAS UNABLE TO PERFORM A SPECIFIC BATCH ANALYSIS AS NO UNIQUE SERIAL IDENTIFIERS WERE PROVIDED ASSOCIATED WITH LOT NZA22040112. HOWEVER, DATA REVIEW OF THE LOT WAS CONDUCTED WHICH DID NOT IDENTIFY A MANUFACTURING FLAW OR DEFECT THAT WOULD CONTRIBUTE TO THE REPORTED GRAFT FAILURES. NO NEGATIVE TREND WAS NOTED FOR THE REPORTED FAILURE MODE AND PRODUCT TYPE IN THE DATA REVIEW. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. EXAMPLES INCLUDE DECREASED BLOOD SUPPLY AT THE SURGICAL SITE, POOR SOFT TISSUE COVERAGE, WEIGHT, INFECTION, POOR GLYCEMIC CONTROL, MEDICATIONS (E.G. STEROIDS), PHYSICAL LOCATION OF THE SURGICAL SITE, ALLERGIC REACTIONS TO BOVINE MATERIAL, BACTERIAL OR VIRAL INFECTION, INFLAMMATION, OR NON-ADHERENCE TO IMPLANT PACKAGE INSERT INSTRUCTIONS. CUMULATIVE RISK FACTORS INCREASE THE LIKELIHOOD OF COMPLICATIONS. ADDITIONAL INFORMATION IS NEEDED TO BETTER UNDERSTAND AND POSSIBLY EXPLAIN THE REPORTED COMPLICATIONS. INFORMATION REGARDING MEMBRANE REHYDRATION PROCESS PRIOR TO USE, SUTURE PROCEDURE AND SUTURE MATERIAL UTILIZED, WHETHER THE MEMBRANES WERE FIXATED UNDER TENSION, OTHER PRODUCTS USED IN THE CASE (SEALANTS), AND IF THE PATIENT HAD AN ALLERGY TO BOVINE COLLAGEN AND/OR BOVINE MATERIAL. BASED ON THE COMPLAINT DESCRIPTION AND THE DATA REVIEW RESULTS FOR THE PRODUCT LOT, IT IS MORE PLAUSIBLE THAT THE PATIENT'S ADVERSE EVENT IS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE DURAFLEX GRAFT.

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE RECORDS RE-REVIEW WILL BE CONDUCTED. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RTI SURGICAL INC. (RTI) RECEIVED A COMPLAINT ON (B)(6) 2023. THE REPORTED COMPLAINT INDICATED THAT THE PATIENT HAD A CHIARI MALFORMATION AND UNDERWENT A SURGICAL PROCEDURE WITH IMPLANTATION OF AN INTEGRA DURAFLEX SUTURABLE GRAFT (LOT # IS UNKNOWN) ON (B)(6) 2023. ON 09/16/2023, THE PATIENT UNDERWENT EMERGENCY SURGERY FOR INCISION AND DRAINAGE PROCEDURE IN THE POSTERIOR NECK DUE TO A CEREBROSPINAL FLUID LEAK. DURING THE PROCEDURE, VISUAL EXAMINATION OF THE GRAFT SHOWED THE GRAFT HAD THINNED OUT AND LEAKAGE WAS PRESENT IN THE MIDDLE OR THE INTERIOR PORTION OF THE GRAFT; THE GRAFT HAD DISSOLVED IN THE MIDDLE. (MANUFACTURER REPORT 3002719998-2023-00018; VOLUNTARY REPORT MW5146289). A SECOND INTEGRA DURAFLEX SUTURABLE GRAFT WAS THEN IMPLANTED (LOT # NZA19460204; MANUFACTURER REPORT 3002719998-2023-00019; VOLUNTARY MW5146291). THE GRAFT WEAKENED IN THE MIDDLE DURING IMPLANTATION AND WAS REMOVED. A THIRD INTEGRA DURAFLEX SUTURABLE GRAFT WAS THEN IMPLANTED (LOT # NZA22040112; MANUFACTURER REPORT 3002719998-2023-00020; VOLUNTARY REPORT MW5146291) WHICH ALSO DISSOLVED IN THE MIDDLE AND WAS EXPLANTED. LASTLY, A DURAGEN® SUTURABLE GRAFT (NOT MANUFACTURED BY RTI) WAS IMPLANTED. ON 09/25/2023, THE PATIENT UNDERWENT ADDITIONAL INTERVENTION DUE TO THE DETERIORATION OF THE DURAGEN® IMPLANT NEAR THE SUTURE LINE. THE HOLES AROUND THE SUTURE LINE HAD ENLARGED RESULTING IN THE GRAFT BEING EXPLANTED AND REPLACED WITH A NEW PRODUCT (BRAND AND MANUFACTURER ARE UNKNOWN). TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733753 DURAFLEX DURAL GRAFT BOVINE PERICARDIUM DURAL SUBSTITUTE GXQ TUTOGEN MEDICAL, GMBH NZA22040112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention