Tritanium TL 48930000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327370096), received between Aug 16, 2018 and Apr 13, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Mechanical Jam

  A COMPANY REPRESENTATIVE REPORTED THAT THE LOCKING MECHANISM ON A TRITANIUM TL STEERABLE INSERTER WAS JAMMING DURING CAGE INSERTION 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 24867571 ↗
• MalfunctionDec 22, 2025Difficult to Insert; Difficult to Remove; Mechanical Jam; Difficult to Insert; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT A TRITANIUM TL STEERABLE INSERTER AND A TRITANIUM TL STEERABLE INSERTER SHAFT WERE JAMMING INTRA-OPERATIVELY AND WERE UNABLE TO INSERT A CAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING DIFFERENT INSTRUMENTS WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874055 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311293 ↗
• 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 INSERTER 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 15691152 ↗
• MalfunctionJan 17, 2022Mechanical Jam; 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 INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267466 ↗
• MalfunctionAug 4, 2021Mechanical Jam; Mechanical Jam

  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 JAMMED TRITANIUM TL INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278021 ↗
• MalfunctionMay 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE IMPLANT INSERTION A TRITANIUM TL INSERTER WOULD NOT RELEASE THE CAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 60 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904300 ↗
• MalfunctionNov 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY A TRITANIUM TL INSERTER WOULD NOT RELEASE THE IMPLANT AT THE DESIRED LOCATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY BY UTILIZING ANOTHER INSERTER AND IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10786660 ↗
• MalfunctionJun 25, 2019Mechanical Jam; Defective Device; Mechanical Jam

  IT WAS REPORTED THAT THE INSERTER HANDLE MOVES BUT THE IMPLANT DOES NOT. THERE WERE NO ADVERSE CONSEQUENCES RESULTING FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732904 ↗
• MalfunctionAug 16, 2018Mechanical Jam

  IT WAS REPORTED THAT THE STEERABLE INSERTER'S BLACK KNOB GOT STUCK. ADDITIONALLY, WHILE ATTEMPTING TO ROTATE THE IMPLANT ON THE INSERTER, IT ROTATED INITIALLY AND THEN GOT STUCK. THIS EVENT OCCURRED DURING DEVICE INSPECTION, PRIOR TO THE PLANNED SURGICAL PROCEDURE. THE PROCEDURE WAS RESCHEDULED FOR THE FOLLOWING DAY, AND WAS COMPLETED SUCCESSFULLY USING A PL CAGE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7791064 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanics Altered; Mechanical Jam

  IT WAS REPORTED THAT THE STEERABLE INSERTER WOULD NOT ARTICULATE IN SURGERY. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A STRAIGHT INSERTER, AND THERE WAS A SURGICAL DELAY OF 1 MINUTE DUE TO IDENTIFICATION OF THE MATTER PRIOR TO INSERTING THE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7789692 ↗
• InjuryAug 16, 2018Mechanical Jam; Positioning Problem; Mechanical Jam

  IT WAS REPORTED THAT THE STEERABLE INSERTER WOULD NOT ARTICULATE IN SURGERY. THE SURGEON FLIPPED THE PATIENT TO BEGIN AN ANTERIOR PROCEDURE TO RETRIEVE THE CAGE, AS THE CAGE HAD ADVANCED MORE ANTERIOR THAN ANTICIPATED DURING THE INITIAL POSTERIOR PROCEDURE. THERE WAS A SURGICAL DELAY OF ABOUT 1 HOUR.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 7789690 ↗