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ENDOSKELETON TT 4200-1040Recalls & reported problems

Titan Spine, LLC · CURVED, 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 M682420010400), received between Jul 14, 2016 and Jul 14, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 14, 2016Break

    IMPLANTING THE TT IMPLANT WITH A TT CURVED IMPLANT HOLDER, THE SURGEON WAS JUST PUSHING WITH HAND (NOT HAMMER) AND IN THE MOMENT OF THE PLACEMENT IN THE DISC, THE ANGLED IMPLANT INSERTER BROKE. THE INNER PART IN ONE SIDE AND THE OTHER PART AND THE IMPLANT IN OTHER SIDE. THE IMPLANT WAS ABLE TO BE RETRIEVED FROM THE DISC SPACE BY HOLDING THE SMALL EXTREME OF THE INNER PART THAT REMAINED. THE PROCEDURE WAS FINISHED USING ANOTHER TT IMPLANT AND THE TT STRAIGHT IMPLANT INSERTER. THE SURGERY TIME DID NOT SUFFER A BIG DELAY AND THE PATIENT IS OK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5797048 ↗

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Sources and updates

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