A REVIEW OF THE DEVICE LOT HISTORY RECORDS WAS PERFORMED. BASED ON THE REVIEW RESULTS, THE NON-CONFORMANCE HAD NO IMPACT ON THE REPORTED ISSUE. A TOTAL OF SEVEN (7) DEVICES WERE PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. A REVIEW OF THE IFU INDICATED THAT ?INFECTION, ALLERGIC REACTION, AND ACUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION)? ARE POTENTIAL COMPLICATIONS. THE IFU ALSO NOTES THAT IF THESE ?CONDITIONS OCCUR AND CANNOT BE RESOLVED, CAREFUL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED." A ROOT CAUSE, OF THE PATIENT?S POST-OP REDNESS AND SWELLING, IS INCONCLUSIVE. THE PRESENCE OF EOSINOPHILS IN THE PATHOLOGY REPORT SUGGESTS THAT THE PATIENT MAY HAVE BEEN HAVING A REACTION TO SOMETHING. HOWEVER, AN ALLERGIC REACTION SPECIFICALLY TO THE DEVICE WAS NEITHER CONFIRMED NOR RULED OUT. IT IS UNKNOWN WHAT ADDITIONAL MEDICATIONS, FLUIDS DURING SURGERY, POST-OP DRESSINGS / WOUND CARE WAS UTILIZED ON THE PATIENT. AN ALLERGIC REACTION TO ANY OF THESE ADDITIONAL FACTORS, INCLUDING THE MONOCRYL SUTURE, WAS ALSO NEITHER CONFIRMED NOR RULED OUT.
D
Patient 1
ON (B)(6) 2017, DR. (B)(6) IMPLANTED AN AXOGUARD NERVE PROTECTOR FOR A RIGHT CARPAL TUNNEL REVISION. MONOCRYL SUTURE WAS USED. THE PATIENT WAS A (B)(6) FEMALE WITH ARTHRITIS AND HIGH BLOOD PRESSURE AND (B)(6). APPROXIMATELY TWO TO THREE WEEKS LATER, DR. (B)(6) NOTED THE SURGICAL AREA WAS VERY RED AND SWOLLEN. THE INCISION WAS INTACT AND THERE WAS NO OPEN WOUND. HE REPORTED THE PATIENT HAD A REACTION TO THE DEVICE. ON (B)(6) 2017, DR. (B)(6) REOPERATED ON THE PATIENT TO EXPLANT THE DEVICE. DR. (B)(6) REPORTED THE OPERATION WAS DIFFICULT. THE ENTIRE AREA AROUND THE NERVE WAS A SHEET OF SCAR TISSUE. THERE WAS NO OVERT SIGN OF INFECTION. DR. (B)(6) HAD TO ?DIG THE NERVE OUT OF THE SCAR? WITHOUT DAMAGING IT. A LARGE AMOUNT OF SYNOVITIS (INFLAMMATION OF THE SYNOVIAL MEMBRANE) WAS PRESENT. A FLEXOR TENOSYNOVECTOMY WAS ALSO PERFORMED. SPECIMENS WERE SENT FOR CULTURE AND PATHOLOGY. THE PATHOLOGY REPORT INDICATED THAT THE AXOGEN GRAFT BIOPSY RESULTS WERE FIBROSIS WITH ASSOCIATED MILDLY ACUTELY AND CHRONICALLY INFLAMED GRANULATION TISSUE AND SOME NONVIABLE TISSUE, POSSIBLY INFARCTED. NO GRANULOMATOUS INFLAMMATION WAS PRESENT. EOSINOPHILS WERE PRESENT RANGING FROM MILD TO MODERATE WITHIN THE GRANULATION TISSUE CONTIGUOUS TO THE NONVIABLE TISSUE, PRESUMABLE COLLAGEN GRAFT. THE SHEATH OF THE RIGHT WRIST BIOPSY SHOWED BENIGN FIBROADIPOSE TISSUE WITH FIBROSIS AND FOCAL GRANULATION TISSUE WITH MILD INFLAMMATION MOSTLY CHRONIC. THERE WAS NO GRANULOMATOUS INFLAMMATION PRESENT.