UNK - FIBULINK
Received May 8, 2026
Report 8030965-2026-04417 · MDR key 25125215
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
32 YR · Male
- Unspecified Infection
Narrative
Description of Event or Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). IT WAS REPORTED THAT A DATA USE AGREEMENT (DUA) REPORT WAS RECEIVED WHICH INCLUDES SAFETY RELATED DATA ON " FIBULINK SYSTEM": PATIENT NUMBER 14: THE PATIENT IS A 32-YEAR-OLD MALE IMPLANTED WITH QTY 1 FIBULINK (RGS-1100) SYNDESMOSIS REPAIR KIT TITANIUM AND QTY 1 SYNTHES 2.7MM MINIFRAG PLATE AND NO ADDITIONAL SCREWS. HE EXPERIENCED INFECTION REQUIRING REMOVAL OF HARDWARE AT 5 WEEKS. IMPLANT INVOLVE(S): QTY 1 - FIBULINK (RGS-1100) SYNDESMOSIS REPAIR KIT TITANIUM. QTY 1 - SYNTHES 2.7MM MINIFRAG PLATE.
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: A1: PATIENT NUMBER 14. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.