SYNFIX EvolutionRecalls & reported problems across all models
Synthes GmbH · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 131
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 21 models of SYNFIX Evolution by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 131 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2016 and Sep 29, 2026 — classified as 17 injuries, 114 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SYNFIX Evolution problems
Device problems
- Compatibility Problem22
- Device-Device Incompatibility20
- Material Integrity Problem20
- Break19
- Mechanical Problem13
- Material Twisted/Bent10
- Mechanical Jam9
- Failure to Cut8
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient32
- No Patient Involvement24
- No Code Available14
- Insufficient Information5
- Injury4
- No Known Impact Or Consequence To Patient4
- Foreign Body In Patient3
SYNFIX Evolution models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNFIX Evolution 03.835.004IMPACTOR46 reports
- 16 reports
- SYNFIX Evolution 03.835.010SCREWDRIVER12 reports
- SYNFIX Evolution 03.835.013SCREWDRIVER10 reports
- SYNFIX Evolution 03.835.015SCREWDRIVER8 reports
- SYNFIX Evolution 03.835.100TEMPLATE6 reports
- SYNFIX Evolution 03.835.005IMPACTOR5 reports
- SYNFIX Evolution 04.835.220.02SIntervertebral fusion device with integrated fixation, lumbar5 reports
- SYNFIX Evolution 03.835.006Intervertebral fusion device with integrated fixation, lumbar4 reports
- SYNFIX Evolution 03.835.003Intervertebral fusion device with integrated fixation, lumbar3 reports
- SYNFIX Evolution 03.835.222TEMPLATE2 reports
- SYNFIX Evolution 03.835.002Intervertebral fusion device with integrated fixation, lumbar2 reports
- SYNFIX Evolution 03.835.012SORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SYNFIX Evolution 04.835.125.02SIntervertebral fusion device with integrated fixation, lumbar2 reports
- SYNFIX Evolution 04.835.225.02SIntervertebral fusion device with integrated fixation, lumbar2 reports
- SYNFIX Evolution 03.835.049TRAY, SURGICAL1 report
- SYNFIX Evolution 08.815.241SIntervertebral fusion device with integrated fixation, lumbar1 report
- SYNFIX Evolution 08.815.323SIntervertebral fusion device with integrated fixation, lumbar1 report
- SYNFIX Evolution 08.815.122SIntervertebral fusion device with integrated fixation, lumbar1 report
- SYNFIX Evolution 03.835.432Intervertebral fusion device with integrated fixation, lumbar1 report
- SYNFIX Evolution 04.835.120.02SIntervertebral fusion device with integrated fixation, lumbar1 report
Recent SYNFIX Evolution adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Cut
It was reported the awls in the synfix evo trays are dull. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933052 ↗MalfunctionSep 29, 2026Failure to Cut
It was reported the awls in the synfix evo trays are dull. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933026 ↗MalfunctionSep 29, 2026Failure to Cut
It was reported the awls in the synfix evo trays are dull. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933018 ↗MalfunctionSep 29, 2026Failure to Cut
It was reported the awls in the synfix evo trays are dull. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932988 ↗MalfunctionSep 29, 2026Failure to Cut
It was reported the awls in the synfix evo trays are dull. No patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932973 ↗MalfunctionSep 29, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932791 ↗MalfunctionMay 5, 2026Failure to Cut; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN INSPECTING INSTRUMENTS RECEIVED THROUGH DECONTAMINATION, PRIOR TO STERILIZATION - THE SYNFIX EVOLUTION AWLS AND 2 SCREWDRIVER SHAFTS WERE OBSERVED TO BE WORN. THE AWL WAS NO LONGER SHARP AND THE DRIVER TIPS WERE BEGINNING TO STRIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082861 ↗MalfunctionMay 5, 2026Failure to Cut; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN INSPECTING INSTRUMENTS RECEIVED THROUGH DECONTAMINATION, PRIOR TO STERILIZATION - THE SYNFIX EVOLUTION AWLS AND 2 SCREWDRIVER SHAFTS WERE OBSERVED TO BE WORN. THE AWL WAS NO LONGER SHARP AND THE DRIVER TIPS WERE BEGINNING TO STRIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082860 ↗MalfunctionMay 5, 2026Material Integrity Problem
IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN INSPECTING INSTRUMENTS RECEIVED THROUGH DECONTAMINATION, PRIOR TO STERILIZATION - THE SYNFIX EVOLUTION AWLS AND 2 SCREWDRIVER SHAFTS WERE OBSERVED TO BE WORN. THE AWL WAS NO LONGER SHARP AND THE DRIVER TIPS WERE BEGINNING TO STRIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082753 ↗MalfunctionMay 5, 2026Material Integrity Problem
IT WAS REPORTED ON AN UNKNOWN DATE, THAT WHEN INSPECTING INSTRUMENTS RECEIVED THROUGH DECONTAMINATION, PRIOR TO STERILIZATION - THE SYNFIX EVOLUTION AWLS AND 2 SCREWDRIVER SHAFTS WERE OBSERVED TO BE WORN. THE AWL WAS NO LONGER SHARP AND THE DRIVER TIPS WERE BEGINNING TO STRIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082691 ↗MalfunctionApr 1, 2026Compatibility Problem
IT WAS REPORTED THAT THE SCREWDRIVER, INTENDED TO CONNECT TO THE SYNFIX SPACER TRIALS, WOULD NOT SEAT FLUSH WITH THE TRIALS AND THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758446 ↗MalfunctionMar 26, 2026Break
IT WAS REPORTED THAT A MINI OPEN AWL INSTRUMENT IS BROKEN. THE METAL RING THAT THE SILICON SITS ON IS BROKEN. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702544 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, THE SYNFIX EVOLUTION PLATE SEPARATED FROM PEEK IMPLANT. IMPLANT WAS NOT USED. REP SELECTED SIMILAR IMPLANT SIZE AND WAS USED IN THE PATIENT. THERE WAS A 10 MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270211 ↗MalfunctionJul 21, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE INSERTION INSTRUMENT AND SLEEVE DID NOT FUNCTION PROPERLY. THE OUTER SLEEVE DOES NOT RETRACT AND IS VERY DIFFICULT TO SEPARATE. THERE WAS NO CONSEQUENCES FOR THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554377 ↗MalfunctionJun 5, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT THE DRIVER ON THE SET IS NOT RETAINING ITS POSITION AT ALL AND IS MAKING PLACEMENT OF THE SCREWS VERY DIFFICULT. SURGERY COMPLETED WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150621 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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