AXOGUARD HA+ NERVE PROTECTOR

Description of Event or Problem

THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT REGARDING A 70 YEAR OLD FEMALE PATIENT WHO UNDERWENT REVISION CARPAL TUNNEL RELEASE SURGERY WITH IMPLANTATION OF AXOGUARD HA+ NERVE PROTECTOR AND SUBSEQUENTLY DEVELOPED MEDICAL DEVICE SITE INFLAMMATION; MEDICAL DEVICE SITE SWELLING. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION CARPAL TUNNEL RELEASE AND MEDIAN NERVE NEUROMA MANAGEMENT, DURING WHICH AXOGUARD HA+ NERVE PROTECTOR WAS USED TO CIRCUMFERENTIALLY WRAP THE MEDIAN NERVE AND SECURED WITH NYLON SUTURES. STANDARD PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT REPORTEDLY DID WELL INITIALLY. AT THE 3 MONTH POSTOP FOLLOW UP, THE SURGEON OBSERVED LOCALIZED SWELLING AT THE IMPLANT SITE, RAISING CONCERN FOR AN INFLAMMATORY REACTION. MRI WAS PERFORMED. DUE TO FINDINGS, THE DECISION WAS MADE TO EXPLANT THE DEVICE AND PERFORM NEUROLYSIS. THE EXPLANT PROCEDURE WAS COMPLETED ON (B)(6) 2026.