BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-GUARD PERICARDIUM WITH APEX PROCESSING

    MDR report key: 2979087 · Received February 26, 2013

    Report

    Report Number
    2032282-2013-00025
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    GXQ
    PMA / PMN Number
    K982282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: FURTHER CLINICAL INVESTIGATION REVEALS A SERIES OF RISK FACTORS THAT USUALLY CONTRIBUTE TO A SURGICALLY INDUCED CONTAMINATION: USE OF SEVERAL DIFFERENT IMPLANTS (MEDPOR SURGICAL IMPLANT, A POLYETHYLENE IMPLANTS FOR CRANIOFACIAL RECONSTRUCTION AND AUGMENTATION; FOUR BURR HOLE COVERS, AND 18 NEURO SCREWS); DURATION OF SURGERY MORE THAN 4 HOURS (303 MINUTES); AND SURGERY PERFORMED BY SAME SURGEON IN SAME OR. WHILE UNDER THESE CIRCUMSTANCES CONTAMINATION DUE TO DURA-GUARD IS UNLIKELY, STILL TO THE KNOWN CHARACTERISTIC OF ANY IMPLANTABLE COLLAGEN TO POTENTIALLY AUGMENT THE INFECTIOUS RESPONSE TO SURGICAL FIELD CONTAMINATION, WE CANNOT RULE OUT THAT THE PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED INFECTIOUS COMPLICATION. THE DURA-GUARD IFU ADEQUATELY REFERS TO THIS RISK AND THE MEASURES TO BE TAKEN. BAXTER SYNOVIS COMPLETED THE INVESTIGATION. SAMPLE EVALUATION COULD NOT BE PERFORMED AS NO SAMPLE WAS AVAILABLE. BATCH RECORD REVIEW WAS PERFORMED AND THE STERILITY RECORDS INDICATE THAT ALL TESTING FOR THIS PRODUCT WAS NEGATIVE. THERE WERE NO REPORTS OF ISSUES THAT MAY HAVE CONTRIBUTED TO A BREACH OF THE STERILE BARRIER AND ALL SPECIFICATIONS WERE MET. PER SYNOVIS, THE ENVIRONMENTAL MONITORING RECORDS REVEALED NO ASPERGILLUS FUMAGATUS WAS DETECTED WHILE PROCESSING THE REPORTED PRODUCT LOT. THERE EXISTS NO INFORMATION THAT DIRECTLY TIES THE DURA-GUARD PRODUCT TO THE EVENT. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THE COMPLAINT WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THIS IS ONE OF TWO CASES FROM ONE DEPARTMENT THAT EXPERIENCED POSTOPERATIVE INFECTION IN SURGERIES IN WHICH DURA-GUARD HAS BEEN USED. IN ONE CASE (B)(6) AND THE OTHER ASPERGILLUS HAVE BEEN IDENTIFIED. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE. EVEN IF THE BATCH REVIEWS PROVE (B)(6) AND THE IMPLANT WOULD HAVE BEEN NON-CONTAMINATED UNTIL ITS SURGICAL HANDLING AND APPLICATION, DUE TO THE KNOWN CHARACTERISTIC OF ANY IMPLANTABLE COLLAGEN (LOT AND PRODUCT INDEPENDENT) TO POTENTIALLY AUGMENT THE INFECTIOUS RESPONSE TO SURGICAL FIELD CONTAMINATION, WE CANNOT RULE OUT THAT THE PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED INFECTIOUS COMPLICATION. THE DURA-GUARD IFU ADEQUATELY REFERS TO THIS RISK AND THE MEASURES TO BE TAKEN. BAXTER IS CURRENTLY WORKING TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    (B)(6), CONSUMER SAFETY OFFICER FOR THE FDA, MADE BAXTER AWARE OF TWO (2) PRODUCT COMPLAINTS WHERE 2 PATIENTS ACQUIRED POSTOPERATIVE WOUND INFECTIONS AFTER DURA-GUARD WAS USED) IN INFECTIONS AT (B)(6) HOSPITAL. LOT NUMBER 5803795-1857120, EXP: 19-JUN-2017 14X8 - ORGANISM: (B)(6). EVENT HANDLED UNDER BAXTER COMPLAINT: (B)(4) (MRN: 2032282-2013-00024). LOT NUMBER 5799286-1802145, EXP: 27-MAR-2017 8X6 - ORGANISM: ASPERGILLUS EVENT HANDLED UNDER BAXTER COMPLAINT: (B)(4) (THIS EVENT). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83094 DURA-GUARD PERICARDIUM WITH APEX PROCESSING DURA SUBSTITUTE GXQ SYNOVIS SURGICAL INNOVATIONS 5799286-1802145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other