ENDOSKELETON® TT 4200-1001Recalls & reported problems
Titan Spine, LLC · Implant Holder Assembly, Straight · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191375002987), received between Feb 22, 2018 and Dec 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADED TIP OF THE HOLDER BROKE OFF. THE PRODUCT WAS NOT IMPLANTABLE, AND NO FRAGMENT OF THE INSTRUMENT REMAINED IN A PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678032 ↗MalfunctionJul 12, 2021Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PATIENTS FOR TLIF SPINAL THERAPY. IT WAS REPORTED THAT TLIF INSERTER BROKE WHILE INSERTING CAGE, TIP OF INSERTER STUCK INSIDE CAGE. NO PATIENT INJURY OCCURRED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12148701 ↗MalfunctionFeb 22, 2018Break; Break
IT WAS REPORTED THAT THE TT CAGE INSERTER BROKE WHILE THE SURGEON WAS INSERTING THE CAGE DURING A PLIF PROCEDURE. THIS WAS THE FIRST OF TWO CAGES TO BE INSERTED. THE INSIDE PIECE THAT THREADS WITH THE CAGE BROKE OFF. THE SECOND TT INSERTER FROM THE SET WAS USED. THE MALFUNCTION DID NOT HAVE AN ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7290811 ↗
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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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