Zyston Interbody Spacer System 14-533127Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663155205), received between Dec 22, 2025 and May 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Fracture

  IT WAS REPORTED THAT A PIECE FRACTURED OFF A CURVED PEEK SPACER INTRA-OPERATIVELY. AFTER THE IMPLANT WAS INSTALLED AND THE INSERTER WAS DETACHED, THE SURGEON FURTHER IMPACTED THE SPACER INTO THE DISC SPACE WHEN A PIECE OF THE SPACER BROKE OFF. SINCE THE SPACER NEEDED TO BE INSERTED FURTHER, THE SURGEON ELECTED TO REMOVE AND REPLACE IT WITH A SECOND SPACER. HOWEVER, DURING REMOVAL, THE METAL PIVOTING PIECE OF THE IMPLANT BROKE OUT OF THE SPACER. THE REMAINDER OF THE PEEK PORTION OF THE SPACER WAS JUDGED TO HAVE SUFFICIENT FIXATION AND REMAINS IN-SITU. THERE WAS A DELAY OF 20 MINUTES TO THE PROCEDURE, BUT THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284430 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING THE ZYSTON CAGE AT T11/12 DURING A POSTEROLATERAL LUMBAR FUSION, THE PEEK CHIPPED. THE FRAGMENT WAS REMOVED BUT THE CAGE REMAINED IMPLANTED AND THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT HARM OR DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868296 ↗