PN 319-1024, 2.4 MM X 10 DEGREE EXTREMIFUSE IMPLANT WAS IMPLANTED IN THE 3RD AND 4TH TOE OF A PT ON (B)(6) 2013. DURING THE ONE WEEK POST-OP VISIT, THE DOCTOR TOOK AN X-RAY AND NOTICED THAT THE MIDDLE PHALANX OF THE 3RD TOE WAS FRACTURED. A DECISION WAS MADE BY THE DOCTOR NOT TO REMOVE THE IMPLANTS AND SEE IF THE FRACTURED TOE WOULD HEAL. NOTIFICATION WAS RECEIVED ON (B)(6) 2013 THAT BECAUSE THE BONE IN THE TOE HAD NOT HEALED, THE DOCTOR HAD DECIDED TO REMOVE THE IMPLANTS IN THE 3RD AND 4TH TOE ON (B)(6) 2013. THE DOCTOR REMOVED THE IMPLANTS AND PERFORMED A MIDDLE PHALANGECTOMY (SURGICAL EXCISION OF THE PHALANX OR DIGITAL BONES) ON THE 3RD AND 4TH TOE AND FUSED THE REMAINING JOINT. ACCORDING TO INFO RECEIVED ON (B)(6) 2013 FROM THE TERRITORY MANAGER, THE DOCTOR STATED THAT THE PT IS DOING WELL AND THE TOES LOOK GOOD.
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THE IMPLANTS WERE NOT RETURNED FOR EVAL. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. NO OTHER RELATED COMPLAINTS OR NON-CONFORMANCES FOR THE EXTREMIFUSE IMPLANTS HAVE BEEN RECEIVED SINCE LAUNCH. IT WAS NOT DETERMINED IF THE BARBS OF THE IMPLANT CAUSED THE FRACTURE OF THE 3RD TOE. THERE MAY BE SEVERAL REASONS FOR IMPLANT FAILURE. THE IFU STATES THAT THE USE OF AN INCORRECTLY SIZED IMPLANT IN AREAS OF HIGH FUNCTIONAL STRESSES MAY LEAD TO IMPLANT FAILURE. THE IFU ALSO STATES THAT THE SURGEON MUST EXERCISE REASONABLE JUDGMENT WHEN DECIDING WHICH EXTREMIFUSE IMPLANT TYPE TO USE FOR SPECIFIC INDICATIONS. THE IMPLANT IS OFFERED IN 2 DIAMETERS SIZES OF 2.4 MM AND 3.0 MM AND CONFIGURATIONS OF 0 DEGREES AND 10 DEGREES. THE OSTEOMED EXTREMIFUSE SYSTEM IS RECOMMENDED FOR USE IN PTS WITH SUFFICIENT BONE QUALITY TO SUSTAIN EFFECTIVENESS AND BENEFITS OF RIGID FIXATION. THE IFU GIVES INSTRUCTIONS IF REMOVAL OF THE IMPLANT IS NECESSARY BEFORE FUSION HAS OCCURRED AND INSTRUCTIONS IF REMOVAL IS NECESSARY AFTER FUSION HAS OCCURRED. IT WAS REPORTED THAT THE PT IS DOING WELL AND THE TOE LOOKS GOOD AFTER THE EXPLANT AND SUBSEQUENT PROCEDURE BY THE DOCTOR. COMPLAINTS WILL CONTINUE TO BE TRENDED. IF NECESSARY, PREVENTIVE ACTIONS WILL BE TAKEN.