BioHorizons CTA3810RRecalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 10.5mm, Laser-Lok and RBT, Regular · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons CTA3810R is a tapered, screw-shaped dental implant placed in the jawbone to replace a tooth. Most of the 75 reports describe the implant failing to fuse with the surrounding bone, with several noting it had to be taken out shortly after surgery; all 75 are injuries and no deaths were reported. Reports rose sharply, from 3 in the previous 12 months to 72 in the most recent. 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
- 71
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00847236027315), received between Aug 15, 2025 and Sep 21, 2026 — classified as 71 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (41 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
- Failure to Osseointegrate41
- Use of Device Problem32
- Compatibility Problem1
Patient problems
- Insufficient Information71
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50837236 ↗InjurySep 21, 2026Failure to Osseointegrate
InjurySep 17, 2026Compatibility Problem
Drivers wouldn't engage the implant.
Patient problems: Insufficient Information
MAUDE report 50802801 ↗InjurySep 10, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50721821 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679445 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 10, 2026Failure to Osseointegrate
InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156638 ↗InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 16, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25839367 ↗InjuryJul 15, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 29, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25650789 ↗InjuryJun 23, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 15, 2026Failure to Osseointegrate
InjuryJun 3, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25377176 ↗
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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