ENDOSKELETON® TT 4200-1040Recalls & reported problems
Titan Spine, LLC · Curved Implant Holder · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191375002994), received between Feb 16, 2018 and Apr 1, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR DDD WITH STENOSIS FOR TLIF TITAN TT TECHNIQUE SPINAL THERAPY. IT WAS REPORTED THAT INSERTER WAS IMPACTED WITH A MALLET AND THE ARTICULATING TIP BROKEN AT THE DISTAL JOINT. THE DISTAL PORTION REMAINED THREADED TO THE IMPLANT BUT WAS REMOVED WITHOUT INCIDENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11600948 ↗MalfunctionFeb 16, 2018Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN ENDOSKELETON TT CURVED IMPLANT INSERTER. THIS OCCURRED DURING A TLIF PROCEDURE. THE SALES RE PRESENTATIVE STATED HE DID NOT ATTEND THE CASE BECAUSE THE SURGEON WAS DOING THE CASES WITHOUT INFORMING THE SALES REPRESENTATIVE FROM GMBH. THE SALES REPRESENTATIVE SENT THE SURGEON A SECOND CURVED IMPLANT INSERTER IN CASE OF DAMAGE WITH THE ORIGINAL CURVED IMPLANT INSERTER. THE BROKEN TIP OCCURRED DURING INSERTION IN THE CAGE. THE SURGEON USED THE NEW TT CURVED HOLDER-HANDLE TO COMPLETE THE SURGERY. THERE ARE NO KNOWN ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278738 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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