GIBSON HEALTHCARE MEMBRANE 3-4

Description of Event or Problem

CUSTOMER REPORTED PRE-MATURE RESORPTION OF THE GIBSON HEALTHCARE MEMBRANE 3-4. ON (B)(6) 2025, THE CLINICIAN PREPARED THE AREA FOR BONE GRAFTS. GIBSON HEALTH CARE ALLOGRAFT BONE PARTICULATE (NOT A COLLAGEN MATRIX, INC. PRODUCT) WAS PLACED IN THE EXTRACTION SITES. THE SITE WAS COVERED WITH TWO GIBSON HEALTHCARE MEMBRANES 3-4 (A COLLAGEN MATRIX, INC. PRODUCT). ON A (B)(6) 2025 VISIT, PRIMARY WOUND CLOSURE WAS NOT ACHIEVED. CUSTOMER REPORTED AT THIS VIST, THE MEMBRANES WERE MISSING AND MUCH OF THE GRAFT WAS LOST. THE SURGICAL SITE WAS ALLOWED TO GRANULATE IN AND THE GINGIVA CLOSED SUCCESSFULLY AT (B)(6) 2025 VISIT. HOWEVER DUE TO THE LOSS OF MEMBRANES, MOST OF THE GRAFT MATERIAL WAS LOST AND THERE WAS SIGNIFICANT RIDGE LOSS. MEDICAL INTERVENTION REQUIRED TO ADJUST THE DENTURE ON (B)(6) 2025, (B)(6) 2025 AND (B)(6) 2025. ON (B)(6) 2025, THE CLINICIAN PLACED A TREATMENT RELINE (COE SOFT; NOT A COLLAGEN MATRIX, INC. PRODUCT). ADDITIONAL INFORMATION WAS REQUESTED, INCLUDING PATIENT STATUS, PATIENT OUTCOME, AND IF ANY OF THE APPOINTMENTS WERE REGULARLY SCHEDULED APPOINTMENTS, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED.