BioHorizons TP3IARecalls & reported problems
Biohorizons Implant Systems, Inc · 3.0mm Implant Analog · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847236010720), received between Aug 19, 2025 and Oct 29, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS REPORT INDICATES A SINGLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS AN EXPERIENCED A CONNECTION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413483 ↗InjuryAug 19, 2025Fracture; Fracture
THE COPING WILL NOT SEPARATE FROM THE ANALOG.
Patient problems: Insufficient Information
MAUDE report 22838644 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.