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Patient 1
TO DATE, THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO SURGICAL SPECIALTIES CORPORATION FOR ROOT CAUSE ANALYSIS. THE LOT NUMBER HAS NOT BEEN PROVIDED WHICH PRECLUDES A DHR REVIEW FROM BEING PERFORMED AT THIS TIME. UNFORTUNATELY WITHOUT THE DEVICE OR LOT INFORMATION WE ARE UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION RECEIVED ABOUT THE EVENTS, SURGICAL SPECIALTIES CORPORATION THE FILE WILL BE RE-OPENED. PDO (POLIDIOXANONE) MATERIAL IS ESSENTIALLY ABSORBED BETWEEN 182 AND 238 DAYS POST IMPLANTATION. HOWEVER, THIS SPECIFIC MATERIAL HAS IN VIVO STRENGTH RETENTION FOR UP TO SIX (6) WEEKS. ALL SUTURES ARE TECHNICALLY ?FOREIGN SUBSTANCES? THAT THE HUMAN BODY HAS A TENDENCY TO REJECT. IDEALLY THIS MEANS THE BODY BREAKS THEM DOWN AND DISSOLVES THEM OVER A PERIOD OF 3 OR 4 MONTHS. STILL IN SOME CASES, THE BODY DECIDES NOT TO BREAK THEM DOWN BUT INSTEAD PUSHES THEM OUT THROUGH THE TOP OF THE SKIN. THAT IS WHY IT IS NOT UNCOMMON FOR SPITTING SUTURES TO OCCUR. SPITTING OF SUTURE MATERIAL CAN ALSO BE THE RESULT OF PLACING THE MATERIAL TOO SUPERFICIALLY. THE SUTURE SIZE, TYPE, DEPTH, AND TECHNIQUE UTILIZED FOR EACH SPECIFIC PROCEDURE CAN BE AN IMPORTANT FACTOR IN DETERMINING AN EXACT ROOT CAUSE FOR THIS TYPE OF EVENT. WITHOUT RECEIVING DETAILED INFORMATION REGARDING THE PROCEDURE, TECHNIQUE AND POST-OPERATIVE DETAILS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.