SYNFIX Evolution 04.835.120.02SRecalls & reported problems
Synthes GmbH · SYNFIX® EVOLUTION FINE TIP SCREW/20MM - 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 20705034816118), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2020Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT A & P LUMBAR FUSION PROCEDURE, WHILE INSTRUMENTING L4-L5 ONE OF OUR SYNFIX EVOLUTION FINE TIP SCREWS/20MM STERILE TORQUED OUT EARLY. WHEN PLACING THE NEXT SCREW, THEY WERE UNABLE TO ADVANCE IT ALL THE WAY DOWN. THE SURGERY SPENT APPROXIMATELY FIFTEEN (15) MINUTES TRYING TO REMOVE THE SCREW THAT WOULD NOT ADVANCE. HOWEVER, THEY NOTICED THAT THE SCREW COULD NOT ADVANCE BECAUSE THE PREVIOUS SCREW WAS NOT COMPLETELY DOWN. THE SURGEON DROVE THE SCREW TO THE TORQUED EARLY DOWN AND WAS ABLE TO ADVANCE THE OTHER SCREW. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER: (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNFIX® EVOLUTION FINE TIP SCREW/20MM - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10382036 ↗
Other Intervertebral fusion device with integrated fixation, lumbar devices
- PIVOX™ Oblique Lateral Spinal System 2161001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, lumbar182 reports
- IdentiTi 232-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall8 reports
- IdentiTi 232-10-85-250Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall5 reports
- IdentiTi 132-10-85-300Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall3 reports
- IdentiTi 232-10-85-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall2 reports
- MectaLIF Anterior 03.30.301Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall2 reports
- IdentiTi 232-11-90-350Alphatec Spine, Inc. · Intervertebral fusion device with integrated fixation, lumbar1 recall1 report
- MectaLIF Anterior 03.30.300Medacta International SA · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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