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ACIS® ProTi 360™ HL 208843005Recalls & reported problems

Tyber Medical, LLC · ACIS PROTI 10 DG HL M 6MM H · 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 00819917021912), received between Feb 10, 2022 and Feb 10, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Nerve Damage1
  • Osteolysis1

Recent adverse event reports

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

  • InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE SURGEON USED ACIS PROTI AND HE PUT THE GRASP INTO DEEP AND LOSS SOME MOTOR FUNCTION IN THE PATIENT. THIS REPORT IS FOR (1) ACIS PROTI 10 DG HL M 6 MM H. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: Nerve Damage; Osteolysis

    MAUDE report 13506647 ↗

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Sources and updates

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