SYNFIX Evolution 03.835.222Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034813387), received between Feb 5, 2020 and May 12, 2020 — 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.

• MalfunctionMay 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR AN ANTERIOR LUMBAR INTERBODY FUSION ON AN UNKNOWN DATE. DURING THE SURGERY THE MEDIUM SYNFIX EVOLUTION TRAIL IS THREADED AND WILL NOT LOAD INTO THE TRIAL HOLDER. THE TRIAL WAS REMOVED FROM HOLDER AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN HOLDER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10047573 ↗
• MalfunctionFeb 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SURGEON WAS USED TRAILED IMPLANT BUT THE SYNFIX EVOLUTION TRIAL MEDIUM HEIGHT WOULD NOT COME OFF THE TRIAL IMPLANT HOLDER. WHEN THE NURSE WAS TRYING TO DISENGAGE THE TRIAL FROM THE EVOLUTION SPINDLE THAT GOES DOWN THE TRIAL IMPLANT HOLDER TO ENGAGE THE TRAIL WOULD UNWIND TO DISENGAGE THE KNOB HOWEVER THE LONG SHAFT WAS STUCK AT THE THREADED PORTION OF THE SPINDLE. THE IMPLANT TRIAL IS STUCK ONTO THE IMPLANT HOLDER (2-PIECE INSTRUMENT) IN SIMPLER TERMS. IT COULD NOT DISENGAGE THE TRIAL FROM THE TRIAL HOLDER. THERE WAS 30 MINUTES DELAY OF SURGERY AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS THE REPORT OF (1) SYNFIX EVOLUTION TRIAL IMPL MED H12 14°. THIS IS REPORT 03 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671162 ↗