SYNFIX Evolution 03.835.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034814131), received between May 3, 2019 and Jun 7, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT WHEN THE INSTRUMENTS WERE BEING DISASSEMBLED AFTER A SPINAL FUSION CASE ON (B)(6) 2023, THE COUPLING SCREW COULD NOT BE REMOVED FROM THE AIMING DEVICE. THE COUPLING SCREW APPEARED TO BE BENT. THE PATIENT WAS UNAFFECTED. THIS REPORT INVOLVES ONE COUPLING SCREW FOR SYNFIX® EVO AIMING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077528 ↗
• MalfunctionOct 11, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SCREW DOES NOT FIT WELL, THE TIP DOES NOT COME OUT TO GRAB THE IMPLANT. THIS REPORT IS FOR ONE (1) COUPL-SCR F/SYNFIX EVOL AIM DEV THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580517 ↗
• MalfunctionOct 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNFIX EVOLUTION AIMING DEVICE AND COUPLING SCREW FOR SYNFIX EVOLUTION AIMING DEVICE WERE BROKEN DURING THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) COUPL-SCR F/SYNFIX EVOL AIMING DEVICE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616427 ↗
• InjuryMay 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR SPINAL FUSION PROCEDURE USING WITH SYNFIX EVOLUTION SYSTEM. DURING THE PROCEDURE, AN UNKNOWN IMPLANT WAS INSERTED WITH A CORRECTLY ATTACHED SYNFIX EVOLUTION AIMING DEVICE HOLDER AND SYNFIX EVOLUTION AIMING DEVICE, BUT THE COUPLING FOR AIMING DEVICE HOLDER REMAINED INSIDE. WHEN THE COUPLING WAS REMOVED, THE COUPLING SCREWDRIVER WAS NOT REMOVED BY PULLING COUNTER COUNTERCLOCKWISE WHEN IT WAS STILL ENGAGED WITH THE HOLDER. IT WAS ONLY RELEASED WHEN THE SURGEON PULLED THE COUPLING SCREWDRIVER. THE SURGEON DID NOT RECOGNIZE DUE TO THE COUNTERCLOCKWISE TURNING, IT LOOSENED THE COUPLING SCREW AND AIMING DEVICE WHERE THE IMPLANT WAS NO LONGER FULLY FIXED. AS A RESULT, DURING SUBSEQUENT PILOT HOLE CREATION AND SCREW INSERTION, THE TRAJECTORY WAS NOT 100% CORRECT DUE TO THE LOOSENED AIMING DEVICE. ONCE THE SURGEON GOT AWARE OF THE ROOT CAUSE HE REMOVED ALL SCREWS, TIGHTENED THE AIMING DEVICE ON THE IMPLANT AGAIN AND RE-INSERTED ALL SCREWS WITHOUT ANY FURTHER PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED NUMBER OF MINUTES OF SURGICAL

  Patient problems: Injury; No Code Available

  MAUDE report 8579430 ↗