ENDOSKELETON® TT 4200-1036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191375030201), received between Jan 8, 2021 and May 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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.

• MalfunctionMay 5, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY FOR AN L4-5 LUMBAR FUSION. IT WAS REPORTED THAT THE INSERTER BROKE INTRA-OPERATIVELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE INSERTER THREADED TIP BROKE OFF WHEN THE SURGEON WAS PLACING CAGE IN THE DISC SPACE. ALL PIECES WERE REMOVED AND RETRIEVED EXCEPT THE PIN THAT HELD THE THREADED TIP ON WAS SUCKED UP INTO THE NEPTUNE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076890 ↗
• MalfunctionJul 12, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TLIF INSERTER BROKE DURING INSERTION OF A TITAN TT IMPLANT. THE PART OF THE INSERTER THAT THREADS INTO THE CAGE BROKE DURING INSERTION. WE HAD TO USE A HOSPITAL INSTRUMENT TO GRAB AND UNTHREAD IT FROM THE CAGE IN ORDER TO GET IT OUT. THE SCREWDRIVER TIP BROKE DURING INSERTION OF AN ILIAC SCREW. THE BONE WAS SO HARD, THAT IT PUT A LOT OF TORQUE AND STRESS ON THE DRIVER. I DID NOT REALIZE THE DRIVER HAS SHEERED OFF UNTIL THE NEXT DAY WHEN I WAS PUTTING UP THE SET. THE TIP OF THE DRIVER REMAINS IN THE TULIP HEAD OF THE SCREW AND IS LOCKED IN PLACE BY THE ROD AND SET SCREW.  IT WAS REPORTED THAT THE FRAGMENT OF THE DRIVER WAS NOT REMOVED. IT IS INSIDE THE SCREW LOCKED IN PLACE BY THE ROD AND SET SCREW. NO ADDITIONAL INTERVENTION IS PLANNED OR WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148761 ↗
• MalfunctionJul 12, 2021Break; Break

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISK DISEASE FOR TLIF SPINAL THERAPY AT L2/3. IT WAS REPORTED THAT THE INSERTER BROKE AFTER IT WAS IMPACTED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148726 ↗
• MalfunctionApr 6, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR FUSION THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROKEN OFF WHEN BEING MALLETED INTO THE PATIENT. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH 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 11617388 ↗
• MalfunctionJan 8, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  THE INFORMATION WAS RECEIVED FROM A HEALTH CARE FACILITY VIA A MANUFACTURING REPRESENTATIVE FOR PATIENT REGARDING TLIF INTERBODY FUSION OF THE LUMBER SPINE FOR IMPLANTING A TITAN TT SPACER AT L4-L5 SPINAL THERAPY. IT WAS REPORTED THAT WHILE IMPACTING THE TITAN TT INTERBODY CAGE INTO THE DISC SPACE, THE INSERTER ATTACHED TO THE CAGE RELEASED AND WAS NO LONGER POSITIVELY CONNECTED TO THE CAGE. THE INTERNAL MECHANISM IN THE INSERTER THAT THREADS INTO THE CAGE BROKE OFF AND FELL APART IN THE PATIENT. THE THREADED PORTION HAD TO BE REMOVED WITH A NEEDLE DRIVER AS IT WAS STILL THREADED IN TO THE CAGE AND THE SPRING WAS LOOSE IN THE DISC SPACE. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WAS NO FURTHER COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138052 ↗