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Patient 1
THIS IS THE SECOND OF THREE REPORTS CONCERNING THE SAME PATIENT. THIS REPORT CONCERNS PRODUCT ID PNG-230 NEURAGEN 2MM X 3CM GUIDE LOT 1094602. IT WAS REPORTED THAT TENOGLIDE AND NEURAGEN NERVE GUIDES WERE IMPLANTED IN 4 FINGERS OF THE RIGHT HAND OF A PATIENT DURING SURGERY ON (B)(6) 2011 TO REPAIR A 4 DIGIT LACERATIONS. THE PATIENT EVENTUALLY RECOVERED SENSATION AND MOVEMENT OF THE AFFECTED FINGERS POST OPERATIVELY. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SWELLING OF HIS FINGERS AND THE INABILITY TO ATTAIN FULL FLEXION OF HIS INDEX FINGER. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. THE INDEX FINGER WAS EXPLORED. A NEURAGEN NERVE GUIDE WAS FOUND TO BE INTACT (OVER 2 YEARS AFTER IMPLANTATION) AND THE SITE WHERE TENOGLIDE WAS IMPLANTED HAD DEVELOPED INTO A SOFT-TISSUE MASS THAT REQUIRED REMOVAL FOR RESTORATION OF FINGER FUNCTION. THE MASS WAS REMOVED FROM THE INDEX FINGER. ONLY THE SINGLE (INDEX) FINGER DIGIT WAS EXPLORED. THE OTHER FINGERS WERE NOT EXPLORED. A NEURAGEN NERVE GUIDE WAS FOUND TO BE LOOSENED FROM THE PROXIMAL SIDE OF THE LACERATED NERVE. IT WAS REMOVED FROM THE INDEX FINGER, DISCARDED AND REPLACED WITH A NEW ONE.