SYNFIX Evolution 04.835.220.02SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705034816149), received between May 16, 2018 and Jan 26, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: DURING THE SURGERY, AT THE TIME OF PLACEMENT OF THE CAGE, THE SCREWS COULD NOT BE PLACED. IT WAS ATTEMPTED TO PLACE THE 4 SCREWS, BUT ALL OF THEM ROTATED FALSELY, IT WAS NOT POSSIBLE TO MAKE THE FINAL TORQUE. THE CAGE WAS LEFT WITHOUT SCREWS IN THE PATIENT. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 60 MINUTES. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREW/20MM STERILE-2PK. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18586846 ↗
• MalfunctionJan 25, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: DURING THE SURGERY, AT THE TIME OF PLACEMENT OF THE CAGE, THE SCREWS COULD NOT BE PLACED. IT WAS ATTEMPTED TO PLACE THE 4 SCREWS, BUT ALL OF THEM ROTATED FALSELY, IT WAS NOT POSSIBLE TO MAKE THE FINAL TORQUE. THE CAGE WAS LEFT WITHOUT SCREWS IN THE PATIENT. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 60 MINUTES. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREW/20MM STERILE-2PK. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18581220 ↗
• MalfunctionJan 25, 2024Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: DURING THE SURGERY, AT THE TIME OF PLACEMENT OF THE CAGE, THE SCREWS COULD NOT BE PLACED. IT WAS ATTEMPTED TO PLACE THE 4 SCREWS, BUT ALL OF THEM ROTATED FALSELY, IT WAS NOT POSSIBLE TO MAKE THE FINAL TORQUE. THE CAGE WAS LEFT WITHOUT SCREWS IN THE PATIENT. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 60 MINUTES. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION SCREW/20MM STERILE-2PK THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18581131 ↗
• InjuryMay 16, 2018Failure to Align; Failure to Align

  IT WAS REPORTED ON (B)(6) 2018, PATIENT UNDERWENT INITIAL SURGERY, AN ANTERIOR LUMBER INTERBODY FUSION (ALIF), WITH NON-SYNTHES POSTERIOR HARDWARE, TWO (2) SYNFIX EVOLUTION CAGES, AND EIGHT (8) 20MM SCREWS DUE TO PATIENT HAD RARE CASE SPONDYLOPTOSIS. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 FOR A FULL CORPECTOMY THAT WASN'T COMPLETED DURING THE INITIAL SURGERY, NOT IMPLANTED RELATED. THE SURGEON HAD SOME SIGNIFICANT CHALLENGES DURING THE REVISION. INITIALLY HE ATTEMPTED TO USE THE STRAIGHT DRIVER WITH THE AIMING DEVICE LOADED ON THE IMPLANT. THIS RESULTED IN THE TIP BEING TORQUED OUT. HE THEN TRIED ANOTHER STRAIGHT DRIVER WITHOUT THE AIMING DEVICE LOADED AND WAS UNABLE TO LOOSEN THE SCREW. HE THEN PLACED THE AIMING DEVICE BACK ONTO THE IMPLANT AND ATTEMPTED TO USE THE ARTICULATING DRIVERS. AGAIN, HE WAS UNABLE TO LOOSEN THE SCREWS AND ENDED UP SHEERING THE TIPS OF TWO DRIVERS. AT ONE POINT THE SURGEON USED A MALLET AND ATTEMPTED TO TURN AND HAMMER ON THE STRAIGHT DRIVER SIMULTANEOUSLY WHICH DIDN¿T BREAK THE SEAL EITHER. ULTIMATELY, HE HAD TO USE A METAL CUTTING BURR TO SHAVE/REMOVE THE TIPS OF THE SCREWS. THIS RESULTED IN METAL FRAGMENTS BEING DISPLACED AND THE USE OF KY JEL

  Patient problems: No Code Available

  MAUDE report 7519881 ↗
• InjuryMay 16, 2018Failure to Align; Failure to Align

  IT WAS REPORTED ON (B)(6) 2018, PATIENT UNDERWENT INITIAL SURGERY, AN ANTERIOR LUMBER INTERBODY FUSION (ALIF), WITH NON-SYNTHES POSTERIOR HARDWARE, TWO (2) SYNFIX EVOLUTION CAGES, AND EIGHT (8) 20MM SCREWS DUE TO PATIENT HAD RARE CASE SPONDYLOPTOSIS. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 FOR A FULL CORPECTOMY THAT WASN'T COMPLETED DURING THE INITIAL SURGERY, NOT IMPLANTED RELATED. THE SURGEON HAD SOME SIGNIFICANT CHALLENGES DURING THE REVISION. INITIALLY HE ATTEMPTED TO USE THE STRAIGHT DRIVER WITH THE AIMING DEVICE LOADED ON THE IMPLANT. THIS RESULTED IN THE TIP BEING TORQUED OUT. HE THEN TRIED ANOTHER STRAIGHT DRIVER WITHOUT THE AIMING DEVICE LOADED AND WAS UNABLE TO LOOSEN THE SCREW. HE THEN PLACED THE AIMING DEVICE BACK ONTO THE IMPLANT AND ATTEMPTED TO USE THE ARTICULATING DRIVERS. AGAIN, HE WAS UNABLE TO LOOSEN THE SCREWS AND ENDED UP SHEERING THE TIPS OF TWO DRIVERS. AT ONE POINT THE SURGEON USED A MALLET AND ATTEMPTED TO TURN AND HAMMER ON THE STRAIGHT DRIVER SIMULTANEOUSLY WHICH DIDN¿T BREAK THE SEAL EITHER. ULTIMATELY, HE HAD TO USE A METAL CUTTING BURR TO SHAVE/REMOVE THE TIPS OF THE SCREWS. THIS RESULTED IN METAL FRAGMENTS BEING DISPLACED AND THE USE OF KY JEL

  Patient problems: No Code Available

  MAUDE report 7519876 ↗