AXOGUARD HA+ NERVE PROTECTOR

Additional Manufacturer Narrative

INSUFFICIENT CLINICAL DETAIL IS AVAILABLE TO DETERMINE THE UNDERLYING CAUSE. POTENTIAL CONTRIBUTING FACTORS, INCLUDING SURGICAL TECHNIQUE, WOUND HEALING CONDITIONS, AND PATIENT-SPECIFIC FACTORS, CANNOT BE ASSESSED OR RULED OUT. IN THE ABSENCE OF DIAGNOSTIC DATA OR OBJECTIVE FINDINGS, A DEVICE-RELATED CONTRIBUTION CANNOT BE EXCLUDED.

Description of Event or Problem

THIS IS AN INITIAL, SERIOUS, SPONTANEOUS REPORT REGARDING A PATIENT (UNKNOWN AGE/GENDER) WHO UNDERWENT A NERVE REPAIR PROCEDURE INVOLVING IMPLANTATION OF AXOGUARD HA+ NERVE PROTECTOR AND SUBSEQUENTLY EXPERIENCED WOUND DEHISCENCE AND DEVICE EXTRUSION. ON AN UNKNOWN DATE, PATIENT UNDERWENT A PROCEDURE TO REPAIR THE NERVE IN THEIR THUMB, INVOLVING PLACEMENT OF AXOGUARD HA+. ON AN UNKNOWN DATE, THE HA+ WAS SUBSEQUENTLY EXPLANTED. VARIABILITY IN SURGICAL TECHNIQUE WAS NOTED; HOWEVER, NO OBJECTIVE PROCEDURAL DETAILS WERE AVAILABLE TO ASSESS ITS CONTRIBUTION TO THE EVENT. NO DETAILED INFORMATION IS AVAILABLE REGARDING THE EXTENT OF PATIENT INJURY AND/OR MOBILITY. NO INFORMATION IS AVAILABLE REGARDING PATIENT TREATMENT POST-SURGERY.