InTice™ -C Porous Ti Cervical Interbody System X098-0206-STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X0980206STR1), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173832); they may or may not involve this specific model.

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

• MalfunctionFeb 19, 2025Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  THE MANUFACTURER WAS MADE AWARE OF THIS PRODUCT COMPLAINT ON (B)(6) 2025. IT WAS REPORTED THAT WHILE PERFORMING A 3 LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION, THE SURGEON BELIEVED THE IMPLANT THAT WAS USED MAY HAVE BEEN MISLABELED AS THE INCORRECT SIZE. THE IMPLANT WAS LABELED AS 6MM, HOWEVER THE COMPLAINANT ASSESSED THE IMPLANT AS 5MM. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, HOWEVER THERE WAS A SLIGHT DELAY TO ALLOW THE SURGEON TO REMOVE AND REPLACE THE IMPLANT. THE IMPLANT WAS DISPOSED OF AT THE HEALTHCARE FACILITY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173832. One submission often covers many models, so check the product and lot details in each record.

• Z-0429-2021 · Sep 30, 2020 · Terminated
  XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: