SYNFIX Evolution 03.835.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705034814100), received between Oct 4, 2018 and Jul 21, 2025 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (11 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• 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 4, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT UPON CAGE ATTACHMENT, THE COUPLING DEVICE DIDN'T ATTACH TO SAID ATTACHMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141827 ↗
• MalfunctionMay 28, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED WHEN CHECKING IN INSTRUMENT AND IMPLANT TRAYS, INSTRUMENT 03.835.004 DID NOT FUNCTION PROPERLY. THE QUICK COUPLE MECHANISM TO ATTACH AND DETACH FROM AIMING GUIDE WAS SEIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095998 ↗
• MalfunctionMay 28, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED WHEN CHECKING IN INSTRUMENT AND IMPLANT TRAYS, INSTRUMENT 03.835.004 DID NOT FUNCTION PROPERLY. THE QUICK COUPLE MECHANISM TO ATTACH AND DETACH FROM AIMING GUIDE WAS SEIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095218 ↗
• MalfunctionMar 7, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT FUNCTION OR HOLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553323 ↗
• MalfunctionMar 7, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT FUNCTION OR HOLD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553320 ↗
• MalfunctionOct 31, 2024Material Integrity Problem; No Apparent Adverse Event; Material Integrity Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNFIX EVOLUTION IMPLANT HOLDER SHAFT BENT AND WAS NOT USABLE. THERE WAS NO PATIENT CONSEQUENCE. NO OTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577679 ↗
• MalfunctionOct 11, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON OCTOBER 1 2024, THE AIMING DEVICE HOLDER JAMMED ON INSPECTION. THE SHAFT REQUIRED FORCE TO RETRACT AND THEN BECAME STUCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430826 ↗
• MalfunctionJun 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE THE SYNFIX EVOLUTION SET AND THE INSERTER, AS WELL AS THE SYNFIX EVOLUTION AIMING DEVICE HOLDER IN THE SET BROKE. THIS REPORT IS FOR ONE SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19498351 ↗
• MalfunctionJun 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSERTER IN THE SET IS BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19494256 ↗
• MalfunctionDec 21, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON NOVEMBER 20, 2023, AFTER AN A&P LUMBAR FUSION PROCEDURE, THE TAB RESTRICTING SLEEVE WAS BENT FROM THE ENGAGING AIMING DEVICE DUE TO GETTING STUCK WHEN THE OUTER SLEEVE WAS RETRACTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380350 ↗
• MalfunctionMay 2, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE SCREW IN THE SYNFIX EVO AIMING DEVICE 10.5 PLUS12 BECAME STICKY AND REQUIRED MORE FORCE THAN USUAL. THE SYNFIX EVOLUTION AIMING DEVICE HOLDER CAME IN THE SET PULLED APART, AND IT COULD NOT BE PUT BACK TOGETHER AS IT WAS VERY STIFF. THE SYNFIX EVOLUTION SCREWDRIVER HAD WEAR AND TEAR ON THE DRIVER TIPS, AND FRAYED EDGES. THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857022 ↗
• MalfunctionFeb 21, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH ON (B)(6) 2022, IT WAS NOTICED THAT THE SYNFIX EVOLUTION AIMING DEVICE HOLDER WAS JAMMED. THE ITEMS HAS ONLY BEEN USED 1 TIMES. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR THE SYNFIX AIMING DEVICE HOLDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409229 ↗
• MalfunctionDec 28, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT RATCH HANDLE W/AO QUICK COUPL SM: DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH IT WAS NOTICED THAT THE RUBBER OF THE HANDPIECE COMES OFF. NO SURGERY IMPACT. NO PATIENT IMPACT. SYNFIX® EVOLUTION AIMING DEVICE HOLDER: DURING AN INSPECTION AT THE LOANER SET DEPARTMENT AT LOC UMKIRCH IT WAS NOTICED THAT INNER SHAFT RUNS TOO 'HEAVY. NO SURGERY IMPACT. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1)SYNFIX EVOLUTION AIMING DEVICE HOLDER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062649 ↗
• MalfunctionJun 29, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SYNFIX EVOLUTION AIMING DEVICE HOLDER WAS NOT CONNECTING TO THE SYNFIX EVOLUTION AIMING DEVICE. ANOTHER AIMING DEVICE HOLDER WAS PUT TOGETHER SO WE COULD USE THAT. THAT HOLDER WORKED. THERE WAS SURGICAL DELAY FOR TWO MINUTES AND MORE. PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME/ CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: SPINE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14858568 ↗
• MalfunctionApr 22, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED INTRA - OPERATIVELY WHILST TRYING TO LOAD THE SYNFIX EVOLUTION CAGE ONTO THE INSERTER FOR INSERTION, THE INSERTER WOULDN'T RETAIN THE IMPLANT. UPON CLOSER INSPECTION AND COMPARISON WITH A SECOND INSERTER ON THE SET, IT WAS OBVIOUS THAT TWO LITTLE NIBS WERE MISSING FROM THE DISTAL END OF THE INSERTER. THIS COMPLAINT INVOLVES ONE (1) DEVICE SYNFIX EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186454 ↗
• MalfunctionDec 28, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING LOAN KIT INSPECTION THE AIMING DEVICE DID NOT MOVE FREELY, BECAME CAUGHT ON POINTS DURING ACTUATION, AND WAS DIFFICULT TO DISASSEMBLE. THIS REPORT INVOLVES (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098474 ↗
• MalfunctionJun 9, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT AFTER ASSEMBLING THE INSTRUMENT AS INTENDED, IT WAS IMPOSSIBLE TO TAKE APART OR USE AND WAS COMPLETELY STUCK. THIS WAS DISCOVERED DURING CLEANING AND STERILIZATION. THIS REPORT IS FOR (1) SYNFIX EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967541 ↗
• MalfunctionMar 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNFIX EVOLUTION AIMING DEVICE HOLDER SET STICKS, WILL NOT ATTACH EASILY TO THE AIM DEVICES. IT WAS TESTED PRIOR TO A CASE AND IT WAS NOT WORKING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED. UNKNOWN SYNFIX EVOLUTION AIMING DEVICE (PAR T# UNKNOWN, LOT # UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592307 ↗
• MalfunctionFeb 26, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN UNKNOWN PROCEDURE. IT WAS DISCOVERED THAT THE AIMING DEVICE IS DEFECTIVE. IT WAS UNKNOWN WHEN AND HOW IT¿S OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE SECOND SET. THERE WAS NO PATIENT IMPACT REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388846 ↗
• MalfunctionDec 1, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF), ANTERIOR SPINE FIXATION, THAT THE INNER SHAFT OF THE INSERTER BENT. OPERATING THE TOOL IS DIFFICULT, IMPRECISE AND IT IS PRONE TO COMING APART DUE TO THE FORCES YOU HAVE TO USE ON IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927635 ↗
• MalfunctionSep 22, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE LOAN SET JAMS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10567033 ↗
• MalfunctionSep 22, 2020Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE LOAN SET JAMS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10566996 ↗
• MalfunctionSep 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SYNFIX EVOLUTION AIMING DEVICE HOLDER WAS FAULTY NOT ABLE TO RETRACT AND HOLD AN UNKNOWN AIMING DEVICE. ANOTHER DEVICE WAS USED. THERE WAS A FIFTEEN (15) MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN AIMING DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554604 ↗
• 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) SYNFIX® EVOLUTION AIMING DEVICE HOLDER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10541814 ↗