AXOGUARD HA+ NERVE PROTECTOR

Additional Manufacturer Narrative

THE DEVICE UTILIZATION RECORD SEARCH SHOWED THAT 11 DEVICES FROM LOT LB1639442 WERE UTILIZED. THE RECALL REPORT SHOWED THAT (B)(4) DEVICES FROM LB1639442 WERE SHIPPED AND INVOICED. COMPLAINT LOOKBACK FROM 12FEB26 CONFIRMS THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. PER EVERGEN'S DEVICE HITORY RECORD REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE LOT PRODUCED (B)(4) DEVICES. ACCORDING TO THE DEVICE LOT HISTORY RECORD, ALL DEVICES RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS AND STERILIZATION REQUIREMENTS. A REVIEW OF THE EVERGEN COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS OR FEEDBACK INVOLVING THE REPORTED LOT NUMBER.

Description of Event or Problem

A PATIENT UNDERWENT A PROCEDURE OVER DORSAL RADIAL SUPERFICIAL NERVE BRANCHES AND AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THE PATIENT EXPERIENCED INCISION SITE ERYTHEMA AND WOUND DEHISCENCE. ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF CHROMIC GUT SUTURES PLACED DURING THE PREVIOUS SURGERY DUE TO A REACTION, WITH NEUROLYSIS/NEUROMA, HA+ PLACED TO PROTECT THE NERVES.ON AN UNSPECIFIED DATE, AT THE FIRST POST-OP APPOINTMENT, THE PATIENT EXHIBITED A SMALL AREA OF REDNESS NEAR THE INCISION. THE INCISION THEN DEHISCED AND PROGRESSED TO AN OPEN WOUND. ON (B)(6) 2026, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR SURGICAL EXPLORATION, IRRIGATION AND DEBRIDEMENT (I&D), AND EXPLANT OF THE AXOGUARD HA+. CULTURES/PATHOLOGY WERE OBTAINED, BUT RESULTS HAVE NOT BEEN SHARED WITH AXOGEN AT THIS TIME. FURTHER TREATMENT INFORMATION, SURGICAL TECHNIQUE, AND EVENT OUTCOME ARE UNKNOWN. THE SURGEON REPORTED CAUSALITY AS NOT RELATED, STATED THAT THE PATIENT HAD A PREVIOUS REACTION TO FOREIGN MATERIAL, VARIOUS COMORBIDITIES, AND SEVERAL SURGERIES IN THIS SAME AREA. AXOGEN REPORTED CAUSALITY AS UNASSESSABLE DUE TO THE ABSENCE OF CULTURES/PATHOLOGY, MULTIPLE PLAUSIBLE ALTERNATIVE EXPLANATIONS (INCLUDING PATIENT/SITE-RELATED FACTORS), AND INSUFFICIENT EVIDENCE TO DETERMINE WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED WOUND DEHISCENCE AND ERYTHEMA. LOT HISTORY REVIEW CONFIRMED THAT THE PRODUCT LOT MET ALL SPECIFICATIONS, WITH NO QUALITY ISSUES IDENTIFIED, AND THIS ADVERSE EVENT APPEARS TO BE ISOLATED WITH NO SIMILAR COMPLAINTS REPORTED FOR THE LOT.