Tritanium C 48989000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327346671), received between Dec 7, 2017 and Mar 26, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Difficult to Insert

  A COMPANY REPRESENTATIVE REPORTED THAT THE THREADING OF A TRITANIUM C INSERTER WAS "OFF" INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE COMPANY REPRESENTATIVE INDICATED THAT THE DEVICE WAS DIFFICULT TO ASSEMBLE AND DISASSEMBLE WITH A CAGE INTRA-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699435 ↗
• MalfunctionNov 6, 2025Difficult to Insert; Difficult to Insert

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493051 ↗
• MalfunctionNov 6, 2025Difficult to Insert; Difficult to Insert

  A COMPANY REPRESENTATIVE REPORTED THAT TWO TRITANIUM INSERTERS COULD NOT ADEQUATELY ENGAGE WITH THE CAGE INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE SECOND OF TWO TRITANIUM INSERTERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493049 ↗
• MalfunctionNov 14, 2024Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT A TRITANIUM C INSERTER DEFORMED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685930 ↗
• MalfunctionDec 7, 2017Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; CASPER PINS WERE PLACED IN THE PATIENT AND WHERE A LITTLE TOO CLOSE TO THE ENDPLATE, WHEN SURGEON WENT TO PLACE THE TRIAL IT INTERFERED WITH THE PINS AND SUBSEQUENTLY CAUSED BLEEDING IN THE PATIENT DELAYING THE CASE APPROXIMATELY 15 ¿ 20 MINUTES. ADDITIONAL CONVERSATION WITH THE SURGEON CONCLUDED THAT THE THIS WAS A CRAFTSMANSHIP ERROR BY THE SURGEON AND THAT THE PLACEMENT OF THE PINS WERE NOT APPROPRIATE FOR THE ASSOCIATED TRIAL. REP WAS IN THE CASE AND CONFIRMED THE ABOVE SITUATION AND THAT THERE WAS NO PRODUCT CONCERN. REP REPORTED THE EVENT AS HE HAD THE CONVERSATION WITH THE SURGEON REGARDING THE CRAFTSMANSHIP ERROR CAUSING THE BLEEDING AND THE DELAY IN SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Known Impact Or Consequence To Patient

  MAUDE report 7096000 ↗