BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA BOVINE PERICARDIUM DURAL GRAFT

    MDR report key: 6490269 · Received April 13, 2017

    Report

    Report Number
    3002719998-2017-00006
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    January 25, 2017
    Report Date
    May 25, 2017
    Manufacturer
    RTI SURGICAL, INC
    Product Code
    GXQ
    PMA / PMN Number
    K132850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE XENOGRAFT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A COMPREHENSIVE RE-REVIEW WILL CONDUCTED OF MANUFACTURING RECORDS, STERILIZATION RUN REPORTS, ENVIRONMENTAL MONITORING RESULTS, QUALITY CONTROL / ASSURANCE REVIEWS AND RELEASE, AND THE COMPLAINT DATABASE FOR RELATED COMPLAINTS ASSOCIATED WITH THE LOT. RESULTS WILL BE PROVIDED IN A FOLLOW UP REPORT ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WAS ONE DEPARTURE NOTED DURING MANUFACTURING RECORDS RE-REVIEW ASSOCIATED WITH A POWER OUTAGE. RESULTS OF INVESTIGATION INDICATED THAT THE DEPARTURE DID NOT HAVE A NEGATIVE IMPACT ON XENOGRAFTS MANUFACTURED FROM LOT NZ14510256. XENOGRAFTS FROM THIS LOT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY (TUTOPLAST®; WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING). ENVIRONMENTAL DATA AND RECORDS GENERATED DURING AND AROUND THE TIME OF PROCESSING FOR THE LOT WERE ACCEPTABLE. TO DATE, RTI HAS MANUFACTURED AND DISTRIBUTED 10 BOVINE PERICARDIUM XENOGRAFTS FROM THE LOT WITHOUT RELATED COMPLAINTS. CONCLUSION: RECORDS RE-REVIEW INDICATED THAT SERIAL ID (B)(4) MET ALL RTI SPECIFICATIONS AND RELEASE CRITERIA PRIOR TO DISTRIBUTION. THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH THE LOT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE IMPLANTATION PROCEDURE AND POST-OPERATIVE COMPLICATIONS INCLUDING TREATMENT AND THE CURRENT STATUS OF THE PATIENT. TO DATE, RTI HAS NOT RECEIVED ANY ADDITIONAL INTERVENTION. CULTURE RESULTS PROVIDED ON THE VOLUNTARY MEDWATCH WERE ASSOCIATED WITH A NON-RTI GRAFT. BASED ON OUR RECORDS RE-REVIEW AND THE INFORMATION PROVIDED, THIS EVENT IS UNLIKELY RELATED TO THE RTI BOVINE PERICARDIUM DURAL GRAFT.

    Description of Event or Problem · 1

    RTI SURGICAL, INC RECEIVED A NOTIFICATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH ABOUT A VOLUNTARY MED WATCH REPORT THAT WAS SUBMITTED TO THEM FOR REVIEW. THE REPORT NUMBER IS MW5068140. THE REPORT STATED THAT A PATIENT WITH A HISTORY OF A MENINGIOMA, UNDERWENT A CRANIOTOMY ON (B)(6) 2016 WITH IMPLANTATION OF A DURAL GRAFT (INTEGRA BOVINE PERICARDIUM DURAL GRAFT IS LISTED IN THE REPORT). ON (B)(6) 2017, THE PATIENT RETURNED TO THE OPERATING ROOM FOR INTRACRANIAL INFECTION. THE PATIENT UNDERWENT LEFT CRANIECTOMY, DEBRIDEMENT OF SUBDURAL EMPYEMA. THERE WAS PURULENT MATERIAL NOTED IN THE SUBDURAL SPACE. BONE FLAP, FIXATION CLIPS AND DURAL GRAFT WERE REMOVED. CULTURES OBTAINED FROM A DURAGEN PATCH, LEFT BONE FLAP, SUBDURAL FLUID WERE POSITIVE FOR PROPIONIBACTERIUM ACNES, PROPIONIBACTERIUM GRANULOSUM, COAGULASE NEGATIVE STAPHYLOCOCCUS AND STAPHYLOCOCCUS CAPITIS. THE REPORT CALLS OUT THE INTEGRA BOVINE PERICARDIUM DURAL GRAFT LABEL ID AND CATALOG NUMBER. HOWEVER, THE EVENT DESCRIPTION MENTIONS DURAGEN AS THE DURAL GRAFT INSTEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM INTEGRA LIFESCIENCES. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271432 INTEGRA BOVINE PERICARDIUM DURAL GRAFT DURAL GRAFT GXQ RTI SURGICAL, INC NZ14150256

    Patients

    Seq Age Sex Outcome Treatment
    1 Other