NA 389.151Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034774794), received between Dec 14, 2017 and Dec 14, 2017 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2017Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A REVISION SURGERY OF A PREVIOUSLY IMPLANTED NON-SYNTHES TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) EXPLANT OF AN ALIF (ANTERIOR LUMBAR INTERBODY FUSION) CAGE TRIAL ON (B)(6) 2017, TRIAL SPACER HANDLE BROKE IN-SITU. IT WAS FURTHER EXPLAINED THAT THE INNER STYLET (TRIAL SPACER HANDLE) BROKE OFF IN THE TRIAL; LEAVING THE SYNFIX TRIAL IMPLANT INSIDE THE PATIENT. THE TRIAL WAS IN THE L5-S1 DISC SPACE THE TRIAL WAS RETRIEVED USING A DISTRACTOR AND A CURVED INSTRUMENT. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES DUE TO THE REPORTED EVENTS. THE PROCEDURE WAS COMPLETED WITH THE SAME/LIKE PRODUCT. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. THE BROKEN DEVICES WERE RETURNED TO THE LOANER DEPARTMENT. ALL AVAILABLE INFORMATION HAS BEEN REPORTED. CONCOMITANT DEVICE REPORTED: SYNFIX(TM)-LR TRIAL IMPL 12DEG DEPTH 30 MM/W 38 MM/H 13.5 MM (PART # 03.802.012, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TRIAL SPACER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7118129 ↗