T-PAL™ ProTi 360°™ 108812207Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
All models of T-PAL ProTi 360° (10)
Data updated Oct 18, 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 00819917021738), received between Sep 29, 2021 and Sep 29, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
T WAS REPORTED THAT THIS WAS A TLIF (L4/5/S) FOR TREATING LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2021. AFTER THE SURGEON INSERTED THE CAGE AT L5/S1, HE WAS NOT ABLE TO TURN THE CAGE DUE TO LIMITED INTERVERTEBRAL SPACE AND LESS INTERVERTEBRAL MOBILITY. SO HE TAPPED THE CAGE WITH A HAMMER. AS IMAGES SHOWED SOME AWKWARD SHAPES OF THE CAGE, IT WAS REMOVED FROM THE PATIENT'S BODY. THE CAGE HAD BROKEN, AND THE SURGEON TRIED TO REMOVE A FRAGMENT(S). HOWEVER, THE FRAGMENT(S) HAS BEEN LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS DELAYED OVER 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 12547485 ↗
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 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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