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ENDOSKELETON TT 4200-1021Recalls & reported problems

Titan Spine, LLC · THIN, PUSHER · 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 M682420010210), received between Feb 19, 2016 and Feb 19, 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
  • Positioning Problem1

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.

  • MalfunctionFeb 19, 2016Break; Positioning Problem

    THE SURGEON WAS PERFORMING A POSTERIOR LUMBAR DECOMPRESSION AT L5-S1 WITH INTERBODY FUSION AT L5-S1 WITH TITAN TT AND PEDICLE SCREWS AT L5 AND S1 WITH DEPUY MATRIX. THE SURGEON WAS IN-SERVICED HOW TO USE THE DEVICE PRE-OP. THE DISC SPACE WAS ADEQUATELY CLEARED OF CARTILAGE AND THE SPACE WAS REMOVED AND THE SPACE WAS TRIALED WITH A 10MM TT TRIAL. THE SURGEON TAPPED THE TT IMPLANT INTO THE INTERVERTEBRAL AREA TO THE AGREED UPON DEPTH AND THEN THE INSERTER HANDLE WAS REMOVED. THE FORKED INSTRUMENT (TT THIN PUSHER) USED TO TURN THE TLIF IMPLANT WAS INTRODUCED AND PLACED AGAINST THE IMPLANT IN CORRECT ORIENTATION. THE SURGEON MODERATELY HAMMERED THE INSTRUMENT TRANSFER FORCE INTO THE TT SPACER, BUT THE SPACER WOULD NOT MOVE. AFTER SEVERAL ATTEMPTS, THE SURGEON LOOKED AT THE TIPS TO RE-INSERT CORRECTLY INTO THE IMPLANT AND THIS IS WHEN THE SURGEON NOTICED THE TIP HAD BROKEN OFF. RECENT X-RAYS AND ADDITIONAL X-RAYS WERE TAKEN AND EXAMINED; HOWEVER, THESE DID NOT IDENTIFY THE LOOSE PIECE OF THE METAL TIP. THE SURGEON AND REP MADE A DETERMINATION THAT THE BROKEN PIECE MUST HAVE BEEN TAKEN OUT BY THE SUCKER THAT IS COMMONLY USED TO REMOVE BLOOD FROM THE WORKING AREA. THE SURGEON ALSO APPLIED

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5448567 ↗

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Sources and updates

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