SYNFIX Evolution 03.835.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034814087), received between Jul 9, 2019 and Apr 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Compatibility Problem

  IT WAS REPORTED THAT THE SCREWDRIVER, INTENDED TO CONNECT TO THE SYNFIX SPACER TRIALS, WOULD NOT SEAT FLUSH WITH THE TRIALS AND THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758446 ↗
• MalfunctionJan 27, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE SYNFIX EVOLUTION TRIAL MEDIUM 15MM WOULD NOT DISENGAGE FROM THE EVOLUTION SPINDLE. THE TRIAL WOULD UNWIND TO DISENGAGE THE KNOB, BUT THE LONG SHAFT WAS STUCK AT THE THREADED PORTION OF THE SPINDLE. THERE WAS NO REPORTED SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: SYNCAGE EVOLUTION SPINDLE (PART NUMBER 03.825.002, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) SYNFIX® EVOLUTION TRIAL SPACER HOLDER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11235932 ↗
• MalfunctionFeb 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) 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 EVOL TRIAL IMPLANT HOLDER. THIS IS REPORT 01 OF 03 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9671155 ↗
• MalfunctionDec 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, AT THE END OF THE CASE, I WAS PACKING UP THE SET AND THE SYNFIX EVOLUTION TRIAL M 13.5 10 DEGREE WOULD NOT COME OFF THE TRIAL IMPLANT HOLDER. WHEN I WAS TRYING TO DISENGAGE THE TRIAL 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 THREADER PORTION OF THE SPINDLE. THE IMPLANT TRIAL IS STUCK ONTO THE IMPLANT HOLDER (2 PIECES INSTRUMENT) IN SIMPLER TERMS. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437314 ↗
• MalfunctionSep 12, 2019Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT AFTER PROCEDURE, THE SURGEON TRIED TO REMOVE TRIAL FROM IMPLANT HOLDER. THE TRIAL WAS STUCK AND COULD NOT BE REMOVED, THE ITEM WAS TAGGED. PATIENT STATUS IS UNKNOWN. THE PRODUCT INVESTIGATION WILL BE COMPLETED BY THE INVESTIGATION TEAM DUE TO THE PROVIDED IMAGES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9013908 ↗
• MalfunctionJul 9, 2019Device Difficult to Maintain; Device Difficult to Maintain

  07/11/2019: UPDATE: IT WAS REPORTED THAT THE REASON WHY THE PATIENT UNDERWENT THE PROCEDURE WAS TO REINSTATE LORDOSIS INTO THE LUMBAR SPINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. UPDATED CONCOMITANT DEVICE/S REPORTED TO CAPTURE THE NUMBER OF TRIAL IMPLANTS (3) USED. CONCOMITANT DEVICE/S REPORTED: UNKNOWN TRIAL IMPLANTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 3).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772814 ↗