DURING THE INVESTIGATION OF THIS COMPLAINT, AS THERE WAS NO PRODUCT RETURN, THE COMPLAINT COULD NOT BE FORMALLY DUPLICATED, ONLY VERIFIED BY FEEDBACK PROVIDED BY SALVIN. ALL APPLICABLE DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND RISK ASSESSMENTS WERE REVIEWED, AND NO DISCREPANCIES APPLICABLE TO THIS COMPLAINT WERE NOTED. IT HAS BEEN DETERMINED THAT RESPONSE EXHIBITED IN THE PATIENT CANNOT SOLELY BE ATTRIBUTED TO THE DEVICE, AS THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DISCREPANCIES DURING THE MANUFACTURING OF THIS LOT. A REQUEST FOR ADDITIONAL INFORMATION TO BETTER ADDRESS THE RECORDED RESPONSE WITHIN THE PATIENT, HAS BEEN MADE TO SALVIN.
D
Patient 1
IT WAS REPORTED THAT A PATIENT WHO IS SYSTEMICALLY HEALTHY HAD BONE DEFICIENCY AT TOOTH # 20 AND UNDERWENT A RIDGE PRESERVATION. DURING THE PROCEDURE THE FOLLOWING PRODUCTS WERE USED: LIFENET FDBA, XYMPHONY MEMBRANE AND CHROMIC GUT SUTURES. THE AREA DEFICIENT OF BONE WAS COVERED WITH THE MEMBRANE AND FURTHER COVERED BY THE PATIENT'S SOFT TISSUE. NO PROCEDURAL COMPLICATIONS WERE REPORTED. ON DAY 2 POST-PROCEDURE, THE PATIENT EXHIBITED SIGNS OF AN ALLERGIC RESPONSE. ON DAY 9 POST-PROCEDURE, THE SITE WAS OPENED, AND THE MEMBRANE WAS REMOVED. THE SITE WAS ULCERATED ON THE LINGUAL SIDE AND SWOLLEN ON THE BUCCAL. PER THE SURGEON, THE SITE WAS WARM, RED AND STREAKY LIKE AN ALLERGY. THE FDBA WAS LEFT IN PLACE, AND THE SUTURES HAD ALREADY DISSOLVED. IT WAS REPORTED THAT THE PATIENT REACTION WAS 99% BETTER FOLLOWING REMOVAL OF THE MEMBRANE.