Description of Event or Problem · 0
COLLAGEN MATRIX, INC. RECEIVED MEDWATCH FORM MW5166536-1 FROM THE FDA ON 02/17/2025. THE FORM INDICATES THAT ON (B)(6) 2024, THE PATIENT HAD AN ALLOGRAFT DONE AT AN UNKNOWN SITE/LOCATION. SINCE THEN, THE PATIENT CONTRACTED TUBERCULOSIS (TB) AND HAS BEEN WORKING WITH PHYSICIANS TO GET ON A 9-MONTH ANTIBIOTIC REGIMEN. SINCE THE LAST TIME THE PATIENT TESTED NEGATIVE FOR TB. THE ONLY OTHER PERSON THE PATIENT HAD SUBSTANTIAL CONTACT WITH HAS RECENTLY TESTED NEGATIVE FOR TB. AS A RESULT, IT IS SUSPECTED THAT THE ALLOGRAFT TO BE THE MEANS BY WHICH THE PATIENT CONTRACTED TB. IN THE INITIAL MEDWATCH FORM, THE FOLLOWING PRODUCTS WERE INDICATED AS FOLLOWS: INFORMATION ABOUT THE COMPANIES INVOLVED IN PROVIDING THE BONE TISSUE USED IN (B)(6) ALLOGRAFT: MINEROSS XP, REF: MINXPCAN0.5SM LOT PMCU23K1; USE BY 2026-08-31 MANUFACTURER: COLLAGEN MATRIX INC. DISTRIBUTED BY (B)(4) LOT: FG24030528, CORTICAL AND CANCELLOUS CHIPS 1.0CC QUALITY DEPARTMENT (B)(6). CADAVER BONE TISSUE IMPLANTED IN ALLOGRAFT. COLLAGEN MATRIX, INC. REACHED OUT TO THE INITIAL COMPLAINANT THAT OUR PRODUCT IS A XENOGRAFT (PORCINE ANORGANIC BONE MINERAL) AND NOT AN ALLOGRAFT INITIALLY INDICATED IN THE MEDWATCH FORM. ADDITIONAL INFORMATION RECEIVED ON 03/10/2025 BY THE INITIAL COMPLAINANT "OUR ORAL SURGEON SAID THAT THE PATIENT DID IN FACT RECEIVE HER ALLOGRAFT FROM HUMAN TISSUE, NOT PORCINE AS YOU CLAIM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/19/2025 AFTER A MEETING WITH THE CLINICIAN, IT WAS CONFIRMED THAT MINEROSS XP MANUFACTURED BY COLLAGEN MATRIX, INC. WAS NOT USED IN THE PATIENT'S PROCEDURE. THE PRODUCT USED WAS GENATE BLEND CORTICAL & CANCELLOUS CHIPS (1.0CC), DISTRIBUTED BY BIOHORIZONS, AND LISTED UNDER THE REFERENCE MIN-C1.0 WITH LOT NUMBER FG24030528, EXPIRATION DATE: 02/28/2029. THE PROCEDURE INVOLVED THE EXTRACTION OF TOOTH #3 ON (B)(6) 2024, FOLLOWED BY GRAFTING AT THE SAME SITE ON (B)(6) 2024. A FOLLOW-UP APPOINTMENT TOOK PLACE ON (B)(6) 2024, WITH AN UPDATED CT SCAN ON (B)(6) 2024. THE PATIENT TESTED POSITIVE FOR TB ON (B)(6) 2025, SEVERAL MONTHS AFTER THE SURGERY. IT WAS NOTED THAT THE PATIENT HAD NO SYMPTOMS AND UNDERGOES YEARLY TESTS FOR VIRAL LOAD, WHICH INADVERTENTLY LED TO THE POSITIVE TB TEST. THE PATIENT DID NOT TRAVEL OUTSIDE OF THE US WITHIN THE YEAR OF A DIAGNOSIS. QA ASSESSMENT DETERMINED THAT THE DHR MET RELEASE CRITERIA. QC TESTING FROM THE DHR MET ACCEPTANCE CRITERIA. PRODUCT MEETS REGULATORY REQUIREMENTS.