SYNFIX Evolution 03.835.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034814124), received between May 3, 2019 and Sep 16, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2020, IN STERILE PROCESSING DEPARTMENT, WHILE ASSEMBLING THE SYNFIX EVOLUTION INSTRUMENT SET AFTER A CASE, AN AIMING DEVICE HOLDER WAS JAMMING. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) COUPLING FOR SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10541866 ↗
• MalfunctionMar 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNFIX EVOLUTION AIMING DEVICE HOLDER WAS JAMMED WITH THE COUPLING FOR AIMING DEVICE HOLDER SYNFIX EVOLUTION. THE ISSUE WAS DISCOVERED AT THE STERILE PROCESSING DEPARTMENT. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. CONCOMITANT DEVICE REPORTED: SYNFIX® EVOLUTION AIMING DEVICE HOLDER (PART# 03.835.004, LOT# 4L26073, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9842919 ↗
• InjuryDec 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  REPORTER NAME: (B)(6).

  Patient problems: No Code Available

  MAUDE report 9512492 ↗
• InjuryDec 23, 2019Device-Device Incompatibility; Device-Device Incompatibility

  (B)(6).

  Patient problems: No Code Available

  MAUDE report 9512463 ↗
• 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 8579353 ↗