BioHorizons CTR3810RRecalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 10.5mm, RBT, Regular · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00847236027360), received between Sep 18, 2025 and Sep 30, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Use of Device Problem6
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
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 7, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 17, 2026Use of Device Problem; Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryApr 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 24889687 ↗InjuryApr 6, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24790825 ↗InjuryFeb 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24366130 ↗InjuryFeb 13, 2026Failure to Osseointegrate
InjuryFeb 5, 2026Failure to Osseointegrate
InjuryJan 29, 2026Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23878113 ↗InjuryDec 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23084624 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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