ENDOSKELETON® TT 4200-1035Recalls & reported problems
Medtronic Sofamor Danek, Inc. · Straight Inserter · Class 1
Data updated Oct 18, 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 00191375030195), received between Jun 30, 2022 and Mar 10, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PRE-OP DIAGNOSIS WAS LUMBAR STENOSIS. IT WAS REPORTED THAT, THE TT INSERTER WAS USED TO PLACE THE CAGE. THEN IT WAS USED TO REATTACH TO BACK CAGE OUT. IN THE PROCESS THE INNER SHAFT¿S THREADED TIP WAS DAMAGED. LEVELS TREATED WERE L5-S1. PROCEDURE OR TECHNIQUE PERFORMED WAS POSTERIOR LUMBAR INTERBODY FUSION/TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED. PIECE OF THREAD FROM INSERTER TIP WAS SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24557458 ↗MalfunctionJun 30, 2022Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR EXPLORATION OF L3-S1 FUSION/L5-S1 INTERBODY. PROCEDURE OR TECHNIQUE USED WAS EXPLORATION OF L3-S1FUSION WITH REMOVAL OF L5-S1 INTERBODY. LEVELS IMPLANTED L3-S1. IT WAS REPORTED THAT WHILE REMOVING INTERBODY FROM L5-S1 DISC SPACE THE THREADED PORTION OF THE INSERTER BROKE OFF IN THE THREADED PORTION OF THE CAGE. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. BROKEN FRAGMENT WAS CONFIRMED TO BE CONTAINED WITHIN THE REMOVED INTERBODY. REMOVED INTERBODY WAS NOT MADE AVAILABLE AFTER THE CASE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14868960 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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