SYNFIX Evolution 04.835.225.02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705034816156), received between Apr 11, 2019 and Aug 14, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SYNFIX EVOLUTION SCREW WOULD NOT LOCK INTO SYNFIX EVOLUTION SPACER PLATE. IT WAS NOTED THE SURGEON USED THE CORRECT TECHNIQUE; HOWEVER, THE SCREW STILL WOULD NOT LOCK INTO PLATE. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: SYNFIX EVOLUTION SPACER PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A SYNFIX EVOLUTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893767 ↗
• MalfunctionApr 11, 2019Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent; Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON PERFORMED ANTERIOR LUMBAR INTERBODY FUSION (ALIF) ON (B)(6) 2019 USING SYNFIX EVOLUTION ON A PATIENT THAT PRESENTED WITH A GRADE 2 SPONDYLOLISTHESIS AT L5-S1. HOWEVER, DURING THE CASE, THE SURGEON STATED THAT THE PATIENT HAD POOR BONE QUALITY. DURING TRAILING, THE SURGEON USED SYNFIX EVOLUTION SCREW TO THEN SECURE THE IMPLANT BETWEEN THE VERTEBRAL BODIES WITH NO ISSUE REPORTED. THE SYNFIX EVOLUTION AIMING DEVICE WAS SECURED TO THE IMPLANT TO PLACE THE TITANIUM SCREWS ACCORDING TO THE TECHNIQUE GUIDE FOR SYNFIX EVOLUTION. THE SURGEON ATTEMPTED TO USE THE SYNFIX EVOLUTION AWL FOR THE RIGHT SUPERIOR SCREW ON THE CAGE THAT WOULD BE IMPLANTED ON THE INFERIOR ENDPLATE OF L5. THE SURGEON STATED THAT THE AWL WAS NOT LONG ENOUGH. AS THE SALES CONSULTANT SHARED WITH THE SURGEON THAT THE AWL LENGTH IS 18MM AND SHOULD EXIT THE CAGE, EXPOSING APPROXIMATELY 13MM OF THE DISTAL TIP OF THE AWL INTO THE PATIENT¿S BONE. THE SURGEON STATED THAT HE WAS NOT HITTING ANY BONE AND THAT THE AIMING DEVICE WAS PREVENTING THE AWL FROM ENGAGING THE PATIENT¿S BONE. THE SURGEON STATED THAT HE NEEDED A LONGER AWL TO WHICH SALES CONSULTANT RESPONDED TO HIM THAT THERE IS ONLY ONE AWL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505816 ↗