Endoskeleton TO 3110-2611Recalls & reported problems
Titan Spine, LLC · Interbody Fusion Device 0 Degree Convex PLIF 11mm · Class 2 · Implant
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 M682311026110), received between Sep 27, 2016 and Sep 27, 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Code Available1
- 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.
MalfunctionSep 27, 2016Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
SURGEON WAS DISSATISFIED WITH THE ORIGINAL PLACEMENT AND LACK OF FUSION FOR AN ENDOSKELETON® TO IMPLANT. DURING THE REVISION SURGERY, THE THREADS OF THE ENDOSKELETON® TO IMPLANT WERE DISCOVERED TO BE DAMAGED. THE ENDOSKELETON® TO IMPLANT WAS BEING USED AS AN INTERBODY FUSION DEVICE WITH ADJUNCT PEDICLE SCREWS WHEN THE DAMAGED THREADS WERE DETECTED. A TWO LEVEL LEFT SIDED APPROACH TLIF I-45 I5 S1 BILATERAL POSTERIOR INSTRUMENTATION PROCEDURE WAS PERFORMED. DUE TO THE DAMAGED THREADS OF THE IMPLANT, TLIF EXPLORATION WAS USED FOR THE EXPLANATION OF THE IMPLANT FROM THE PATIENT. THE PLANNED REVISION PROCEDURE WAS COMPLETED AS PLANNED WITH APPROXIMATELY A 15 MINUTE DELAY DUE TO THE DAMAGED THREADING ON THE IMPLANT. NO ADVERSE EFFECTS OR INJURY TO THE PATIENT OCCURRED AS A RESULT OF THE DAMAGED THREADING ON THE IMPLANT.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5982019 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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 13, 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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