Description of Event or Problem · 0
COMPLAINT SUBMITTED THROUGH CLINICAL DATA COLLECTION. LIMITED INFORMATION PROVIDED AND IT IS UNLIKELY FURTHER INFORMATION SURROUNDING THE PATIENT OR THE EVENT WILL BE PROVIDED. DURAMATRX-ONLAY COLLAGEN DURA MEMBRANE USED ON A PATIENT ON (B)((6) 2025 IN THE ANTERIOR FOSSA. PATIENT WAS PART OF CLINICAL STUDY FOR MENINGIOMA WHO GRADE 1. AT TIME OF INITIAL SURGERY, 3-0 AND 4-0 SYNTHETIC, NON-ABSORBABLE SUTURES WERE USED (NOT COLLAGEN MATRIX, INC. PRODUCTS). NO OTHER DURAL PRODUCTS WERE UTILIZED. A DRAINAGE SHUNT WAS ALSO USED (NOT A COLLAGEN MATRIX, INC. PRODUCT). THERE WERE NO COMPLICATIONS NOTED DURING THE INITIAL SURGERY. THERE WAS NO CSF LEAKAGE AFTER INITIAL PLACEMENT. THE CLINICIAN CLASSIFIED THE HANDLING PROPERTIES OF THE DURAMATRIX-ONLAY PRODUCT AS "GOOD" AND ALSO CLASSIFIED THE ADAPTABILITY OF THE PRODUCT TO ANATOMIC STRUCTURE AS "GOOD." AN ADVERSE EVENT WAS REPORTED ON 5/31/2025, IN WHICH AN INTRACRANIAL ABSCESS POST CRANIECTOMY IN THE BONE FLAP WAS NOTED. CLINICIAN CLASSIFIED THIS AS A SERIOUS, BUT UNEXPECTED, ADVERSE EVENT. HOSPITALIZATION WAS REQUIRED. INTERVENTION REQUIRED AS ADDITIONAL SURGERY WAS PERFORMED TO RE-DO THE CRANIECTOMY AND EVACUATION OF ABSCESS AND WASHOUT. A CT/MRI WAS PERFORMED BUT NO FURTHER DETAILS WERE PROVIDED. THE DURAL DEFECT SITE UPON RE-ENTY WAS ADEQUATE. CUSTOMER LISTED (B)(6) 2025 AS THE ADVERSE EVENT STOP DATE, HOWEVER NO DETAILS SURROUNDING THIS WERE PROVIDED. A ROUTINE FOLLOW-UP WAS PERFORMED ON (B)(6) 2025 AND NO FURTHER ADVERSE EVENTS WERE NOTED; CLINICIAN WAS SATISFIED WITH THE PERFORMANCE OF THE DURAMATRIX-ONLAY DEVICE. NO FURTHER DETAILS SURROUNDING THE PATIENT STATUS, PATIENT OUTCOME, OR EVENT WILL BE PROVIDED.