Description of Event or Problem · 0
LIMITED INFORMATION PROVIDED. CLINICAL DATA COLLECTION SITE REPORTED LOSS OF BONE GRAFT MATERIAL AND PARULIS (LOCALIZED COLLECTION OF INFLAMMATION) ON A PATIENT AFTER USING OSSEOGUARD FLEX MEMBRANE PRODUCT DURING A GUIDED BONE REGENERATION IN DEHISCENCE DEFECT PROCEDURE AT TOOTH SITE #13. AN ALLOGRAFT PRODUCT, PUROS, WAS ALSO USED IN CONJUNCTION WITH THE OSSEOGUARD FLEX MEMBRANE PRODUCT (PUROS IS NOT A COLLAGEN MATRIX, INC. PRODUCT). THE MEMBRANE WAS NOT HYDRATED PRIOR TO PLACEMENT. THE MEMBRANE WAS STABILIZED IN PLACE WITH SIZE 4-0 VICRYL SUTURES. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT WAS INSTRUCTED TO USE PERIDEX (AN ANTIMICROBIAL ORAL RINSE, NOT A COLLAGEN MATRIX, INC. PRODUCT) TWICE A DAY FOR 2 WEEKS AFTER THE INITIAL SURGERY. IT WAS NOTED THE PATIENT RETURNED ON (B)(6) 2023 FOR "IMPLANT PLACEMENT FOR DELAYED CASES," IN WHICH REVISION SURGERY WAS REQUIRED TO REDO THE BONE GRAFTING AND REMOVE THE DAMAGED TISSUE (DEBRIDEMENT). THE CLINICIAN NOTICED THE LOSS OF BONE GRAFT MATERIAL AND PARULIS AT THIS TIME AND THE DENTAL IMPLANT PLACEMENT WAS PERFORMED AGAIN. NO INFORMATION ON THE TYPE OF MEMBRANE UTILIZED DURING THE REVISION SURGERY WAS SPECIFIED. AFTER THE REVISION SURGERY, THE PATIENT AGAIN WAS INSTRUCTED TO USE PERIDEX (AN ANTIMICROBIAL ORAL RINSE, NOT A COLLAGEN MATRIX, INC. PRODUCT) TWICE A DAY FOR 2 WEEKS. ADDITIONAL PATIENT INFORMATION, PATIENT IMPACT AND PATIENT STATUS WERE REQUESTED BUT NOT PROVIDED. NO ADDITIONAL INFORMATION SURROUNDING THE EVENT WILL BE PROVIDED.