BioHorizons CTR3812Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 12mm, RBT · Class 2 · Implant
Quick summary
This BioHorizons CTR3812 tapered root-form dental implant is a screw-shaped implant used to anchor a replacement tooth in the jaw. The 75 reports describe the implant failing to fuse with the surrounding bone, with 75 injuries and no deaths, and several reports also mention problems with how the device was used. No recalls name this device. Reports rose sharply in the past 12 months, from 15 to 60.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00847236024321), received between Feb 5, 2025 and Sep 30, 2026 — classified as 79 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (68 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate68
- Use of Device Problem16
Patient problems
- Insufficient Information79
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 19, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 20, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25236518 ↗InjuryMay 4, 2026Use of Device Problem; Failure to Osseointegrate
InjuryApr 28, 2026Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.