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T-PAL™ ProTi 360°™ 108812216Recalls & 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 00819917021820), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate 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

  • Inaccurate Information1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 8, 2020Inaccurate Information; Inaccurate Information

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MISMATCH IN PRODUCT LABELLING BETWEEN SURGICAL TECHNIQUE GUIDE AND THE LABEL ON THE PRODUCT FOR PROTI T-PAL AND PROTIACIS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9936190 ↗

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page