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ACIS® ProTi 360°™ 108843305Recalls & reported problems

Tyber Medical, LLC · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917020489), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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

  • Human-Device Interface Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryAug 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, EXPIRED PRODUCT WAS IMPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17652469 ↗

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Sources and updates

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