ENDOSKELETON® TL 7200-1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191375009269), received between Aug 31, 2017 and Feb 16, 2026 — classified as 6 malfunctions.

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

• MalfunctionFeb 16, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT DURING CLEANING IT WAS NOTED THAT ONE OF THE TIPS OF THE INSTRUMENT WAS BROKEN OFF IN THE TRAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342246 ↗
• MalfunctionMar 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING AN INSERTER AND BLADES USED IN AN OLIF 2-5 AT 3 LEVELS FOR DDD. IT WAS REPORTED THAT UPON RETRACTION USING THE OLIF ANTERIOR BLADES SIZES 15 AND 17, THE BLADES BENT UNDER RETRACTION AND THE SURGEON REQUESTED THAT THE SIZE 15 AND 17 BLADES BE REPLACED AS THE CONCERN WAS THAT THE METAL WAS WEAKENING. UPON INSERTING THE TITAN TL CAGE, THE INSERTER PRONGS THAT FIT INSIDE THE CAGE BROKE OFF. THE LOOSE PIECES FROM THE INSERTER WERE RETRIEVED AND DISCARDED AND THE INSERTER WAS PASSED OFF THE FIELD FOR REPAIR. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617339 ↗
• MalfunctionAug 1, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR DEGENERATIVE DISC DISEASE. PROCEDURE OR TECHNIQUE USED WAS OLIF L3-4. LEVELS IMPLANTED 1. IT WAS REPORTED THAT UPON INSERTION OF THE CAGE, ONE OF THE PRONGS ON THE TIP OF THE INSERTER BROKE OFF. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137328 ↗
• MalfunctionApr 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LATERAL FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14234614 ↗
• MalfunctionFeb 22, 2018Break; Break

  IT WAS REPORTED THAT THE ATTENDING PHYSICIAN HAD AN INCIDENT WITH AN ENDOSKELETON TL THREADED INSERTER AS ONE OF THE TABS THAT'S USED TO STABILIZE THE TRIAL SEEMED TO HAVE SIGNS OF BEING WORN AND BROKE OFF WHEN REMOVING THE TRIAL FROM THE INSERTER AFTER THE CASE WAS FINISHED. THE MALFUNCTION WAS DISCOVERED AFTER THE CASE WHEN THE TRIAL WAS BEING REMOVED FROM THE INSERTER. THE PLANNED XLIF 4-5 PROCEDURE WAS ABLE TO BE COMPLETED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289333 ↗
• MalfunctionAug 31, 2017Break; Detachment Of Device Component

  DURING POST MARKET SURVEILLANCE, AN ENDOSKELETON® TL SURVEY NOTED THAT THE TRIALS ALLOW FOR ADEQUATE SIZING OF THE IMPLANT; HOWEVER, THE TRIAL BROKE DURING THE CASE. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THE INCIDENT THAT LED TO THE TRIAL BREAKING DURING THE CASE. THE FOLLOWING INFORMATION WAS PROVIDED ABOUT THE INCIDENT: DURING A L2-5 OBLIQUE/LATERAL CASE, TWO INSTRUMENT FAILURES OCCURRED. WHILE THE SURGEON WAS USING THE 9MM X 18MM TRIAL (P/N 7300-1109), HE INSERTED THE TRIAL WITH A METAL MALLET. WHILE STEERING THE TRIAL AND AFTER FINALLY GETTING FULLY POSITIONED INTO THE L4-5 DISC SPACE, THE SURGEON REALIZED THE INSERTER WAS NO LONGER FIXED TO THE TRIAL. AFTER INSPECTING THE INSERTER (P/N 7200-1004) IT WAS CLEAR THAT THE POST HAD BROKEN OFF IN THE TRIAL LODGED IN THE L4-5 DISC SPACE. THERE WASN'T ENOUGH POST THAT WAS PROUD OF THE TRIAL TO TRY TO EXTRACT IT TO USE THE SECOND TRIAL INSERTER, SO THE SURGEON HAD TO TRY TO USE VARIOUS CLAMPS TO EXTRACT THE LODGED TRIAL WITH THE SLAP HAMMER (P/N 7200-1065) WITH HOOK ATTACHMENT. IN THAT PROCESS, THE THREADED POST THAT HOOK SCREW ONTO, BROKE. FINALLY, THE SURGEON WAS ABLE TO PRESS THE BOTTOM LIP OF THE SLAP HAMMER AGAINST THE CROSS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835236 ↗