BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH

    MDR report key: 8764869 · Received July 5, 2019

    Report

    Report Number
    3002924436-2019-00007
    Event Type
    Injury
    Date Received
    July 5, 2019
    Report Date
    September 11, 2019
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    GXQ
    PMA / PMN Number
    K081538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE RE-REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. THERE WERE NO DEPARTURES THAT WOULD NEGATIVELY IMPACT THE IMPLANTS MANUFACTURED FROM LOT NZ16480063. BOVINE PERICARDIUM IMPLANTS UNDERGO A VALIDATED STERILIZATION METHOD: TUTOPLAST® WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. MANUFACTURING RECORDS INDICATED THAT SERIAL ID (B)(6) MET ALL SPECIFICATION REQUIREMENTS AT THE TIME OF RELEASE. TO DATE, RTI/TMI HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF (B)(4) IMPLANTS FROM THE LOT WITHOUT RELATED COMPLAINTS. BOVINE MATERIAL IS KNOWN TO POTENTIALLY CAUSE AN ALLERGIC REACTION IN PATIENTS WITH A HYPERSENSITIVITY TO BOVINE MATERIAL. THE DEVELOPMENT OF A FISTULA IN THIS CASE, COULD HAVE BEEN A CONSEQUENCE OF THE ALLERGIC REACTION. ALTHOUGH IT IS VERY UNCOMMON, IT CANNOT BE EXCLUDED THAT THE TUTOPATCH COULD BE THE CAUSATIVE FACTOR FOR THE DEVELOPMENT OF AN ALLERGIC REACTION CONTRIBUTING TO A FISTULA FORMATION.

    Additional Manufacturer Narrative · 1

    THE GRAFT WAS NOT RETURNED FOR EVALUATION. THEREFORE, OUR INVESTIGATION CONSISTS OF A COMPREHENSIVE RECORDS RE-REVIEW OF THE LOT. ONCE RESULTS ARE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL (B)(4) (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON 06/06/2019. THE COMPLAINT INDICATED THAT A (B)(6) FEMALE PATIENT UNDERWENT A SUBOCCIPITAL CRANIOTOMY, RESECTION OF POSTERIOR ATLAS ARC AND BIOPSY OF BULBO-MEDULAR TUMOR, WITH IMPLANTATION OF A TUTOPATCH DURAL PATCH. TISSUCOL (MANUFACTURER UNKNOWN) WAS ALSO UTILIZED DURING THIS PROCEDURE. THREE WEEKS AFTER SURGERY THE PATIENT DEVELOPED DISCOMFORT, SWELLING, INFLAMMATION AND A CUTANEOUS EXANTHEMA IN THE TRUNK WITH HIVES. THE DOCTOR REPORTED AN ALLERGIC REACTION TO THE TUTOPATCH AND CONFIRMED THAT THE PATIENT DEVELOPED A LATE FISTULA OF CEREBROSPINAL FLUID (CSF) AND SHOWED INCREASE EOSINOPHILS IN THE BLOOD AND CSF. ADDITIONAL RELEVANT INFORMATION: PRIOR TO IMPLANTATION, THE GRAFT WAS REHYDRATED FOR 1 MINUTE IN WARM PHYSIOLOGICAL SALINE AND WAS SHAPED WITH STERILE SCISSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557886 TUTOPATCH DURAL PATCH GXQ TUTOGEN MEDICAL GMBH NZ16480063

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other