BioHorizons CTA3812RRecalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 12mm, Laser-Lok and RBT, Regular · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro dental implant has 105 reports, no deaths and 105 injuries. Many reports give little detail, while others describe the implant failing to bond with the jawbone or being removed soon after placement. Reports rose from 1 in the prior 12 months to 104 in the latest 12 months. No recalls name this device.
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
- 103
- Deaths reported
- 0
- Injuries reported
- 103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00847236027322), received between Sep 22, 2025 and Sep 30, 2026 — classified as 103 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (63 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
- Use of Device Problem63
- Failure to Osseointegrate45
Patient problems
- Insufficient Information103
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50789008 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50721816 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721810 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50721808 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721699 ↗InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710617 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710500 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709486 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679391 ↗InjurySep 3, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50581868 ↗InjuryAug 28, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50495600 ↗InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 24, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50401629 ↗InjuryAug 19, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50320294 ↗InjuryAug 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50190486 ↗InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 25826130 ↗InjuryJul 14, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25812712 ↗InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 10, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25781434 ↗
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 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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