NA 03.815.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034728247), received between Oct 26, 2018 and Apr 26, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE LOADING BLOCK IN THE SYNFIX EVOLUTION SET BROKE WHILE TRYING TO LOAD THE INSERTER DURING A TRAINING SESSION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A LOADING BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210804 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT DURING AN INSPECTION OF A SET AT THE LOANER'S DEPARTMENT, IT WAS FOUND OUT THAT THE EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY WAS BROKEN IN THREE PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9119206 ↗
• MalfunctionMar 27, 2019Break; Break

  FURTHER IT WAS REPORTED THAT THE ITEM SNAPPED WHEN TRYING TO DISASSEMBLE THE SYNIF EVO SQUID ON THE ASSEMBLY/DISASSEMBLY BLOCK ON (B)(6)2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456167 ↗
• MalfunctionDec 13, 2018Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) OFFICE PRESENTATION INVOLVED DEMONSTRATING THE EVOLV SQUID SYNTHES DEVICE. THE ISSUE OCCURRED WHEN ASSEMBLING THE EVOLSQUID SYNTHES QUICK INSERT+DISTRACT DEVICE (SILVER RAIL WITH GREEN HANDLE) THAT SLIDES OVER THE EVOLSQUID ASSEMB / DISASSEMB TOOL DEVICE (BLACK THREE PIECE). THIS SLIDING MECHANISM WOULD REMOVE SLICES OF THE BLACK RAIL AND MAKE A CARVING NOISE WHILE SLIDING THE INSERTER OVER IT. THE DEMONSTRATION WAS DONE AROUND TEN TIMES WHEN THE DEVICE BEGINS STRIPPING THE BLACK PLASTIC. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8160469 ↗
• MalfunctionNov 27, 2018Device Damaged by Another Device; Device Damaged by Another Device

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A IN- HOUSE PRODUCT DEMONSTRATION: ALIF PRESENTATION IN THE OFFICE DEMONSTRATING THE SQUID, WHILE PRACTICING PUTTING IT TOGETHER THE FOLLOWING WAS OBSERVED: THE 03.815.030 (SILVER RAIL WITH GREEN HANDLE) WOULD SLIDE OVER THE 03.815.029 EVOL SQUID ASSEMB/DISASSEMB TOOL (BLACK THREE PIECE) HOWEVER THIS WOULD REMOVE SLICES OF THE BLACK RAIL AND MAKE A CARVING NOISE WHILE SLIDING THE INSERTER OVER IT. THIS REPORT IS FOR TWO (2) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8107552 ↗
• MalfunctionOct 26, 2018Break; Break

  IT WAS REPORTED THAT DURING EVALUATION ON AN UNKNOWN DATE, THE EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY WAS FOUND TO HAVE A BROKEN PART. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8010815 ↗