ACIS® ProTi 360°™ 108843306Recalls & reported problems
Tyber Medical, LLC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917020496), received between Aug 8, 2025 and Aug 8, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility2
Patient problems
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
BONE MARROW EDEMA AFTER ACIS PROTI CAGE IMPLANTATION; QUESTIONABLE ALLERGIC REACTION (COBALT - NOT CONFIRMED). PATIENT WILL BE RE-OPERATED ON IN THE NEARER FUTURE, BUT NO DATE PROVIDED, TO REMOVE BOTH CAGES AND REPLACE WITH AUTOGRAFT, ILIAC CREST, AND ANTERIOR CERVICAL PLATE.
Patient problems: Swelling/ Edema
MAUDE report 22755906 ↗InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
BONE MARROW EDEMA AFTER ACIS PROTI CAGE IMPLANTATION; QUESTIONABLE ALLERGIC REACTION (COBALT - NOT CONFIRMED). PATIENT WILL BE RE-OPERATED ON IN THE NEARER FUTURE, BUT NO DATE PROVIDED, TO REMOVE BOTH CAGES AND REPLACE WITH AUTOGRAFT, ILIAC CREST, AND ANTERIOR CERVICAL PLATE.
Patient problems: Swelling/ Edema
MAUDE report 22755905 ↗
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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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