UNK BIO PUTTY/PASTE: PROSIDYAN

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) "EVALUATION OF HEALTHCARE OUTCOMES OF PATIENTS TREATED WITH DEPUY SYNTHES FIBERGRAFT BG MATRIX IN THE APPENDICULAR SKELETON" IN PREMIER HEALTHCARE DATABASE BETWEEN (B)(6) 2017 AND (B)(6) 2024. REPORTED COMPLICATIONS PER ICD 10 DIAGNOSIS CODE, PROCEDURE CODE OR CPT CODE EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: (N=13) NONUNION, 0-730 DAYS POST-INDEX, (N=14) INFECTION, 0-730 DAYS POST-INDEX, (N=27) REVISION, 0-730 DAYS POST-INDEX. THIS IS FOR DEPUY SYNTHES FIBERGRAFT BG MATRIX.