T-PAL™ ProTi 360°™ 108812008Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
All models of T-PAL ProTi 360° (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00819917021639), received between May 13, 2022 and Dec 28, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Expulsion” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Expulsion2
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Expulsion; Expulsion
IT WAS REPORTED THAT THIS WAS A TLIF (L4-5) FOR SPONDYLOLYTIC SPONDYLOLISTHESIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE CAGE IN QUESTION HAD BEEN BACKED OUT. THE REVISION SURGERY WAS PERFORMED. THE POSSIBLE CAUSE OTHER THAN THE CAGE IS A SCREW FROM ANOTHER COMPANY WHICH WAS LOOSE, AND IT MIGHT CAUSE THE INTERVERTEBRAL SPACE TO MOVE AND THE CAGE TO BACK OUT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18409661 ↗InjuryMar 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THIS WAS A TLIF (L4 TO L5) FOR THE SPONDYLOLISTHESIS ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THE CAGE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. IMPLANT DATE (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 16530776 ↗MalfunctionMay 13, 2022Expulsion; Expulsion
ON (B)(6) 2022 THE PATIENT UNDERWENT A PRIMARY TLIF (L4-5) PROCEDURE WITHOUT SURGICAL DELAY. ON AN UNKNOWN DATE IT WAS FOUND THAT THE CAGE HAD BACKED OUT. ON (B)(6) THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE. THE SURGEON WONDERED IF THE CAGE MIGHT HAVE TRIGGERED THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14397556 ↗
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- 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
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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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