SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN

Additional Manufacturer Narrative

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Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: RAZZAQ BW, PASSMAN JN, DIMARIA S, SERVIDER J, KLEYNER RS, SACKS GI, BERGESE S, MUSHLIN H. COMPLEX SPINE SURGERY IN THE SETTING OF ALPHA-GAL SYNDROME. WORLD NEUROSURG. 2026 JAN;205: 124634. DOI: 10.1016/J.WNEU.2025.124634. EPUB 2025 NOV 6. PMID: 41205864. THE PATIENT IS A 71-YEAR-OLD MAN WITH ADULT DEGENERATIVE SCOLIOSIS RESULTING IN INTRACTABLE BACK PAIN, RIGHT L5 RADICULOPATHY, AND WEAKNESS IN RIGHT DORSIFLEXION 4/5. HE HAS A PAST MEDICAL HISTORY THAT INCLUDES UNPROVOKED DEEP VEIN THROMBOSIS (DVT) ON RIVAROXABAN WITH INFERIOR VENA CAVA FILTER PLACEMENT, OSTEOPOROSIS TREATED WITH DENOSUMAB, AND AGS MANIFESTING AS AN URTICARIAL RESPONSE TO RED MEAT. PREOPERATIVE STANDING IMAGING SHOWED A SAGITTAL IMBALANCE OF 18 CM AND DEXTROSCOLIOSIS MEASURING APPROXIMATELY 37 [?] RESULTING IN A CORONAL IMBALANCE OF 10 CM. THE PATIENT WAS PLANNED FOR A T9-PELVIS FUSION WITH MULTIPLE GRADE II SCHWAB OSTEOTOMIES AND INTERBODY PLACEMENT TO CORRECT HIS DEFORMITY. THROUGHOUT THE SURGERY, SURGIFLO AND GELFOAM SOAKED IN THROMBIN HAD BEEN USED FOR HEMOSTASIS, AND THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS AND 1 UNIT OF FRESH FROZEN PLASMA. AFTER PLACEMENT OF THE HARDWARE, THE PATIENT BECAME HYPOTENSIVE AS LOW AS 40/20 MMHG AND WAS TREATED WITH EPINEPHRINE AND DIPHENHYDRAMINE, AS WELL AS A PHENYLEPHRINE DRIP. THE WOUND WAS CLOSED EXPEDITIOUSLY, AND THE PATIENT WAS TAKEN INTUBATED TO THE POST- ANESTHESIA CARE UNIT. A FULL-BODY RASH WAS NOTED. IN CONCLUSION, AGS IS A RARE, ALTHOUGH INCREASINGLY RECOGNIZED, HYPERSENSITIVITY REACTION TO MAMMALIAN PROTEINS. SEVERAL UNIQUE PRE, INTRA, AND POSTOPERATIVE CONSIDERATIONS ARE INVOLVED IN MANAGING PATIENTS WITH AGS UNDERGOING SPINE SURGERY. THOROUGH, MULTIDISCIPLINARY EVALUATION AND PLANNING SHOULD BE PERFORMED BEFORE SURGERY AND INVOLVE ALLERGY/IMMUNOLOGY, ANESTHESIOLOGY, THE OPERATING ROOM TEAM, AND THE SURGICAL TEAM. ULTIMATELY, DUE TO THE PREVALENCE OF ANIMAL PRODUCTS IN COMMON MATERIALS USED IN SPINE SURGERY AND THE SEVERITY OF PATIENT REACTIONS TO THESE MATERIALS, THE DIAGNOSIS OF AGS IMPACTS EACH STAGE OF OPERATIVE CARE. WITH THE INCREASING FREQUENCY OF AGS DIAGNOSES IN RECENT YEARS, IT IS ESSENTIAL FOR SPINE SURGERY TEAMS TO BE WELL EDUCATED IN THE MANAGEMENT OF AFFECTED PATIENTS AND TO HAVE IMMUNOLOGY CONSULTANTS AND ALTERNATIVE MATERIALS READILY AVAILABLE TO OPTIMIZE SURGICAL OUTCOMES. NO PRODUCT IS AVAILABLE FOR EVALUATION.