BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1902279 · Received November 18, 2010

    Report

    Report Number
    1063481-2010-00052
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THERE WAS SUPPURATION OF A POSTOPERATIVE WOUND, AFTER MICRODISCECTOMY ON LEVEL L5SL IN (B)(6) 2009. THE PATIENT WAS OPERATED ON SEVERAL TIMES. EACH TIME INFECTION PARAMETERS WERE EXAMINED, WHICH DID NOT INDICATE AN INFECTIOUS STATE, AND WOULD CULTURES WERE STERILE. IN (B)(6) 2010, DURING A SUBSEQUENT REOPERATION A FORMED ABSCESS IN THE SPINAL CANAL WAS REMOVED WITH INTERNAL CONTENTS OF FRAGMENTS OF SURGICAL ADHESIVE BIOGLUE. QUALITY REVIEWED THE DEICE HISTORY RECORDS THE LOT AND CONFIRMED THE LOT MEET ALL SPECIFICATION DURING MANUFACTURING. A MEDICAL REVIEW OF THE INFORMATION PROVIDED COULD NOT YIELD A DEFINITIVE CONCLUSION. HOWEVER, IT IS LIKELY THAT THIS CASE INVOLVES AN INFLAMMATORY REACTION TO BIOGLUE. THE SURGEON DESCRIBED AN ABSCESS BUT REPORTED THAT ALL CULTURE RESULTS WERE NEGATIVE. THE REPORTED ABSCESS MAY BE "STERILE ABSCESSES," WHICH OFTEN FORM WHEN THE BODY ELICITS A FOREIGN-BODY TYPE INFLAMMATORY RESPONSE. FOR REASONS THAT ARE NOT COMPLETELY UNDERSTOOD, SUCH REACTIONS MAY BE MORE EVIDENT IN SOME INDIVIDUALS. INFLAMMATORY, FOREIGN-BODY TYPE REACTIONS ARE NOT AN UNEXPECTED POTENTIAL COMPLICATION OF BIOGLUE USE. THE POSSIBILITY OF SUCH REACTIONS IS NOTED IN THE PRODUCT'S INSTRUCTIONS FOR USE. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED AND ANY ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THERE WAS SUPPURATION OF A POSTOPERATIVE WOUND, AFTER MICRO-DISCECTOMY ON LEVEL L5S1 IN (B)(6) 2009. THE PATIENT WAS OPERATED ON SEVERAL TIMES. EACH TIME INFECTION PARAMETERS WERE EXAMINED, WHICH DID NOT INDICATE AN INFECTIOUS STATE, WOULD CULTURES WERE STERILE. IN (B)(6) 2010, DURING SUBSEQUENT REOPERATION A FORMED ABSCESS IN THE SPINAL CANAL WAS REMOVED WITH INTERNAL CONTENTS OF FRAGMENTS OF SURGICAL ADHESIVE BIOGLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL GLUE MUQ CRYOLIFE, INC. BG3515-5-G 08SGW042

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other