AXOGUARD HA+ NERVE PROTECTOR
Received Apr 3, 2026 · Event occurred Mar 4, 2026
Report 3017860045-2026-00003 · MDR key 24780735
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
48 YR · Male
- Purulent Discharge
Narrative
Description of Event or Problem
THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT RECEIVED FROM A SALES REPRESENTATIVE VIA SURGEON REGARDING A PATIENT WHO UNDERWENT TARSAL TUNNEL DECOMPRESSION IN WHICH AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED AND EXPERIENCED PURULENT DISCHARGE. ON (B)(6) 2025, THE PATIENT UNDERWENT A TARSAL TUNNEL DECOMPRESSION WHERE AXOGUARD HA+ NERVE PROTECTOR WAS IMPLANTED. THE SURGEON LAID THE HA+ FLAT OVER THE NERVE AND DID NOT SUTURE IT IN PLACE. IN (B)(6) 2026, THE SURGEON WAS MADE AWARE OF CONCERNS FOR A POSSIBLE INFECTION WITH PURULENT DISCHARGE AT THE SURGICAL SITE. DURING EXPLANTATION, THE WRAP FELL APART INTO TWO PIECES AND THE SURGEON NOTED THAT IT ALMOST LOOKED LIKE HA+ WAS EXTRUDING, AS THE MATERIAL WAS LOCATED CLOSE TO THE INCISION SITE UPON OPENING. THE SURGEON CLEANED THE SITE AND PERFORMED CLOSURE IN THE CLINIC.
Additional Manufacturer Narrative
DEVICE UTILIZATION RECORD FOR LOT LB1634940 WAS PULLED ON 05MAR2026. 13 DEVICES FROM THIS LOT HAVE REPORTEDLY BEEN IMPLANTED WITHOUT ISSUE. THE RECALL REPORT FOR THE LOT WAS PULLED ON 06MAR2026. 41 DEVICES FROM THIS LOT HAVE BEEN INVOICED AND SHIPPED. A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO NON-CONFORMANCES WERE IDENTIFIED IN PRODUCTS RELEASED FOR DISTRIBUTION. 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. NO OTHER COMPLAINTS HAVE BEEN REPORTED.