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ACIS® ProTi 360°™ 108843505Recalls & reported problems

Tyber Medical, LLC · Class 2 · Implant

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 00819917020564), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

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.

  • MalfunctionJun 25, 2021Material Fragmentation; Material Fragmentation

    THE SURGEON IMPLANTED THE CERVICAL CAGE WITH THE PLUNGER FROM THE ACIS SET. THE CAGE BROKE ON THE BACKSIDE. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR GREATER THAN 20 MINUTES., DEVICE WAS EXPLANTED AND A REPLACED WITH A NEW DEVICE. PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED., FRAGMENTS WERE REPORTED AS BEING GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12066666 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.