OSSEOGUARD FLEX RESORBABLE COLLAGEN MEMBRANE

Description of Event or Problem

COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. THE PRODUCT THAT IS PART OF THE CLINICAL DATA COLLECTION IS OSSEOGUARD FLEX RESORBABLE COLLAGEN MEMBRANE. THE OSSEOGUARD FLEX MEMBRANE WAS USED IN A PATIENT ON (B)(6) 2024 FOR LOCALIZED RIDGE AUGMENTATION FOR A LATER IMPLANTATION IN TOOTH #30. THE MEMBRANE WAS NOT HYDRATED PRIOR TO PLACEMENT AND WAS USED IN CONJUNCTION WITH AN ALLOGRAFT (BRAND NAME OF ALLOGRAFT NOT SPECIFIED). SUTURES WERE REQUIRED AND THE PRIMARY CLOSURE WAS ACHIEVED. NO COMPLICATIONS WERE NOTED DURING IMPLANTATION, NO CONCOMITANT MEDICAL TREATMENT REQUIRED, AND THE CLINICIAN RATED THE OVERALL HANDLING AND PERFORMANCE OF THE DEVICE AS "EXCELLENT." AN ADVERSE EVENT OF LOSS OF BONE GRAFT MATERIAL WAS NOTED DURING THE FOLLOW-UP VISIT ON (B)(6) 2024. THE PERIODONTAL DEFECT REGENERATION WAS NOT SUCCESSFUL AND THE DENTAL IMPLANT WAS NOT PLACED. THE MEMBRANE WAS NOT VISUALLY PRESENT. CLINICIAN STATED THERE WAS INADEQUATE RIDGE WIDTH. REVISION SURGERY REQUIRED. THE SITE WAS REGRAFTED AND ANOTHER IMPLANT WAS SUCCESSFULLY PLACED (INFORMATION RELATED TO OTHER IMPLANT NOT PROVIDED). NO FURTHER INFORMATION REGARDING EVENT OR PATIENT OUTCOME PROVIDED.