BioHorizons CTR3309Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.3 x 9mm, RBT · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847236024260), received between Mar 24, 2025 and Sep 30, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (16 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 Osseointegrate16
- Use of Device Problem5
Patient problems
- Insufficient Information20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 11, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50211365 ↗InjuryJun 29, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 19, 2026Failure to Osseointegrate
InjuryJun 19, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 3, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25378027 ↗InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryMar 10, 2026Use of Device Problem; Failure to Osseointegrate
InjuryMar 5, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Failure to Osseointegrate
InjuryFeb 10, 2026Failure to Osseointegrate
InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Use of Device Problem; Use of Device Problem
THE DRIVER WAS STUCK IN THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 23365984 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 24, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21683458 ↗
Other Implant, Endosseous, Root-Form devices
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- 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.