OSSIOFIBER HAMMERTOE FIXATION SYSTEM

Additional Manufacturer Narrative

COMPANY WAS NOTIFIED OF A REVISION SURGERY. AN INVESTIGATION WAS PERFORMED BASED ON THE INFORMATION PROVIDED BY THE SURGEON AND PRODUCTION RECORDS. SURGEON REPORTED THAT A PATIENT WHO HAS RHEUMATOID ARTHRITIS (PRE-EXISTING AUTO-IMMUNE DISORDER), HAD WHAT APPEARS AS A LOCAL INFLAMMATORY REACTION, WHICH LED TO REPLACEMENT OF THE IMPLANT WITH A K-WIRE. PATIENT WAS REPORTED TO HAVE HEALED FOLLOWING THE REVISION. THE DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED. NO IMAGING OR TEST RESULTS WERE PROVIDED. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. IMPLANTATION IN PATIENTS WITH AUTOIMMUNE DISORDERS IS NOT SPECIFICALLY CONTRAINDICATED, NEVERTHELESS, COMPANY CANNOT RULE OUT IN ADVANCE AN INFLAMMATORY REACTION IN FACE OF AUTOIMMUNE CONDITIONS. THE IMPLANT INSTRUCTIONS FOR USE RECOMMENDS PRECAUTION AND EVALUATION OF EACH SITUATION INDIVIDUALLY BASED ON THE PATIENT'S HISTORY, CLINICAL PRESENTATION, AND CONCOMITANT MEDICATIONS USE. IT ALSO LISTS AN INFLAMMATORY OR ALLERGIC REACTION AS A POTENTIAL ADVERSE EFFECT TO IMPLANTATION OF FOREIGN MATERIAL. INFLAMMATORY REACTION CAN BE THE RESULT OF NUMEROUS REASONS AND IS A KNOWN INHERENT RISK OF THE DEVICE AND SURGICAL PROCEDURE. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE IS LIKELY THE OUTCOME OF THE PATIENT EXPERIENCING A LOCAL REACTION DUE TO PRE-EXISTING CONDITION, THOUGH OTHER CAUSES COULD NOT BE RULED OUT. BECAUSE THE COMPANY CANNOT RULE OUT THE POSSIBLE CONTRIBUTION OF THE DEVICE TO THE EVENT, OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE INITIAL IMPORTER RELATING TO THIS EVENT IS: #3014323288-2025-00005.

Description of Event or Problem

REVISION PROCEDURE ABOUT 1 MONTH FOLLOWING HAMMERTOE FIXATION SURGERY DUE TO LOCAL INFLAMMATORY REACTION IN A PATIENT WITH RHEUMATOID ARTHRITIS.