NA 03.815.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034728254), received between Nov 27, 2018 and Jan 10, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT ON DURING INSPECTION OF A SET AT THE LOANERS DEPARTMENT (B)(6) 2019, IT WAS FOUND THAT THE TIP OF THE EVOLUTION SQUID SYNTHES QUICK INSERTER AND DISTRACTOR ROD WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EVOLUTION QUICK INSERTER/DISTRACTOR (SQUID). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9575430 ↗
• MalfunctionJun 6, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE EVOLUTION QUICK INSERTER/DISTRACTOR HAD A BENT DETACHABLE BLOCK HOLDER. IT WAS OBSERVED DURING INSPECTION OF SET BY THE LOANERS DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8676344 ↗
• MalfunctionDec 13, 2018Device-Device Incompatibility; 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 QUICK INSERTER/DISTRACTOR (SQUID). THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8160479 ↗
• 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 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8107559 ↗