SynCage 397.087Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034778501), received between May 6, 2021 and May 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• MalfunctionMay 6, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ALIF PROCEDURE, THE SYNCAGE IMPLANT INSERTER KNOB WOULD NOT ROTATE. THE SURGEON WAS UNABLE TO TIGHTEN THE CAGE TO THE INSERTER. NO FURTHER DAMAGE OR PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) SYNCAGE IMPLANT HOLDER- STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783450 ↗