T-PAL™ ProTi 360°™ 108812210Recalls & 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 00819917021769), received between May 22, 2020 and May 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2020Migration; Migration
"ON (B)(6) 2019 A MIS-TLIF (MINIMALLY INVASIVE SURGERY - TRANSFORAMINAL LUMBAR INTERBODY FUSION) WAS PERFORMED TO TREAT RIGHT INTERVERTEBRAL ARTHRITIS IN L5/S. ON (B)(6) 2020 IT WAS REPORTED THAT THE CAGE HAD BACKED OUT. ON (B)(6) THE PATIENT WILL UNDERGO A REVISION PROCEDURE. THE SURGEON COMMENTED AS FOLLOWS: 1. S/HE WONDERED IF EXCESSIVE LOAD MIGHT HAVE PUT THE CAGE TO MOVE BACKWARD DUE TO THE TIP'S TAPERED SHAPE. 2. IN ADDITION TO THE PRODUCT'S DEFECTIVENESS, IF ANY, MISMATCHING OF CAGE SIZE AND/OR THE CAGE'S DEPLOYED LOCATION MIGHT HAVE TRIGGERED THE EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE."
Patient problems: Failure of Implant
MAUDE report 10084045 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- 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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