SYNFIX Evolution 04.835.125.02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705034816125), received between Nov 6, 2018 and Apr 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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.

• InjuryApr 8, 2019Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TWO (2) SYNFIX EVOLUTION SCREW THAT BACKED OUT. THE SCREW WAS COMPLETELY BACKED UP AND NO SYNFIX EVOLUTION INSTRUMENTS WERE NEEDED TO REVISE THE SURGERY. THE SCREW WAS FLOATING. THEY LEFT THE THREE OTHER SCREWS AND CAGE IMPLANTED IN THE PATIENT AND ONLY PULLED OUT THE LOOSE SCREW THAT BACKED OUT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE: TORQUE HANDLE: (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). CAGE/.SPACERS: SYNCAGE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8492976 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WAS PERFORMED AT L4-S1 WITH SYNTHES SYNFIX EVOLUTION. THERE WERE DIFFICULTIES PLACING ONE OF THE S1 SCREWS ON THE L5-S1 LEVEL. AFTER INSERTING THE SPACER AT L5-S1, THE AWL WAS PLACED THROUGH THE AIMING DEVICE TO CANNULATE S1. IT WAS VERY DIFFICULT TO FULLY ADVANCE THE AWL INTO THE "SCLEROTIC" BONE THAT THE PATIENT HAD AT S1. THE AWL APPEARED TO BE 15MM IN LENGTH BUT THE SCREWS BEING USED WERE 25MM. THIS LEFT 10MM OF BONE NOT PREPPED FOR A SCREW. THIS WAS CONFIRMED BY VIEWING THE CT SCAN ON THE IMAGING IN THE ROOM - THE BONE WAS DENSE AND SCLEROTIC. AFTER ADVANCING THE AWL BY MALLETING AND TWISTING, A FINE TIP SCREW WAS PLACED INTO THE HOLE OF S1. AFTER ADVANCING THE SCREW ABOUT 2/3 OF THE WAY THROUGH THAT PLATE ON THE SPACER, THE SCREW WOULD NOT ADVANCE ANYMORE. THE SCREW WAS TAKEN OUT. THE SURGEON WANTED TO DRILL INTO RECANNULATED HOLE DEEPER INTO S1 SO HE COULD ALLOW THE SCREW TO ADVANCE. WITH NO DRILL OPTION, THE AIMING DEVICE WAS ELECTED TO BE TAKEN OFF AND THE AWL "FREEHAND" WAS USED WHICH IS NOT SUGGESTED IN THE TECHNIQUE GUIDE. THE SCREW WAS PLACED WITHOUT THE AIMING DEVICE ATTACHED TO THE SPACER. U

  Patient problems: No Code Available

  MAUDE report 8044111 ↗