Tritanium TL 48930005Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327370133), received between Aug 4, 2021 and Dec 22, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Difficult to Insert; Difficult to Remove; Mechanical Jam; Difficult to Insert; Difficult to Remove; Mechanical Jam

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874056 ↗
• MalfunctionDec 9, 2025Fracture; Difficult to Insert; Mechanical Jam; Fracture; Difficult to Insert; Mechanical Jam

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764365 ↗
• MalfunctionNov 3, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447289 ↗
• MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING CAGE INSERTION A TRITANIUM CURVED POSTERIOR LUMBAR CAGE BECAME JAMMED AND REMAINED STUCK TO A TRITANIUM STEERABLE INSERTER AND A TRITANIUM STEERABLE INSERTER SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT CAGE WITH A 25 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM STEERABLE INSERTER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311286 ↗
• MalfunctionNov 15, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT DURING INSERTION, THE TRITANIUM TL STEERABLE INSERTER INNER SHAFT WOULD NOT RELEASE THE TRITANIUM TL CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT DEVICE WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE TRITANIUM TL STEERABLE INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145342 ↗
• MalfunctionOct 28, 2022Mechanical Jam; Mechanical Jam

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE TRITANIUM TL STEERABLE INSERTER INNER SHAFT JAMMING. THE ASSOCIATED 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 15691427 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT WHILE INSERTING A TLIF CAGE DURING A LUMBAR ARTHRODESIS, THE TIP OF A TRITANIUM TL STEERABLE INSERTER SHAFT BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422122 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE IMPACTING A CAGE, THE TRITANIUM PL STEERABLE INSERTER INSIDE SHAFT BROKE INTRA-OPERATIVELY AFTER SEVERAL BLOWS OF THE MALLET. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135572 ↗
• MalfunctionJan 17, 2022Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT A TRITANIUM TL INSERTER AND INNER SHAFT "NO LONGER HOLDS THE IMPLANT AND CANNOT BE DISASSEMBLED" INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN 8 MINUTE SURGICAL DELAY. THIS RECORD CAPTURES THE INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267473 ↗
• MalfunctionAug 4, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSERTION OF A CAGE, THE TRITANIUM TL INSERTER JAMMED AND THE SURGEON WAS UNABLE TO DISENGAGE THE CAGE FROM THE INSERTER. THE CAGE WAS REMOVED FROM THE SURGICAL SITE (STILL ATTACHED TO THE INSERTER) AND IT WAS THEN NOTED THAT THE TRITANIUM TL STEERABLE INSERTER INNER SHAFT WAS FRACTURED. THIS REPORT CAPTURES THE FRACTURED TRITANIUM TL STEERABLE INSERTER INNER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277968 ↗