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ENDOSKELETON TT 4200-1001Recalls & reported problems

Titan Spine, LLC · STRAIGHT, INSERTER · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682420010010), received between May 4, 2016 and May 4, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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

Device problems

  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 4, 2016Fracture; Fracture

    DURING A TLIF T5 SPINAL FUSION CASE, THE SURGEON HAD THE TIP OF A TT IMPLANT HOLDER SHEAR OFF WHILE ATTEMPTING TO PLACE THE IMPLANT. THE TIP OF THE THREADED HOLDER REMAINED ATTACHED TO THE IMPLANT. THE SURGEON DETERMINED THE IMPLANT WAS IN THE PROPER POSITON WITHIN THE DISK SPACE. THE SURGEON FINISHED THE PROCEDURE WITH NO FURTHER ISSUES. FOLLOW UP X-RAYS CONFIRMED THE PLACEMENT OF THE IMPLANT WITHIN THE DISK SPACE. THERE WERE NO ADVERSE EFFECTS OR INJURY TO THE PATIENT AS A RESULT OF THE TT IMPLANT HOLDER FAILURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5632762 ↗

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Sources and updates

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