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SYNFIX Evolution 08.815.122SRecalls & reported problems

Synthes GmbH · SYNFIX® EVOLUTION SPACER SMALL/12MM HEIGHT/14°-STERILE · Class 2 · Implant

All models of SYNFIX Evolution (21)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034815183), received between May 16, 2018 and May 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    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 Known Impact Or Consequence To Patient

    MAUDE report 7519885 ↗

Other Intervertebral fusion device with integrated fixation, lumbar devices

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Sources and updates

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