BioHorizons TRXP5809Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Platform Switch Implant, 5.8 x 9mm, RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons TRXP5809 is a small tapered dental implant used to replace a tooth root. Most of the 37 reports describe the implant failing to fuse with the surrounding bone, with a few noting it was taken out shortly after placement; all 37 report injuries and no deaths. There are no recalls naming this device, and the reports have stayed fairly steady, from 16 in the earlier 12 months to 14 in the most recent.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00847236012793), received between Apr 10, 2024 and Sep 21, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (32 reports).
1 other recall cover devices cleared under the same FDA submission (K121787, K223697); they may or may not involve this specific model.
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 Osseointegrate32
- Use of Device Problem6
- Osseointegration Problem1
Patient problems
- Insufficient Information38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryMay 14, 2026Failure to Osseointegrate
InjuryMay 14, 2026Failure to Osseointegrate
InjuryFeb 6, 2026Failure to Osseointegrate
InjuryJan 12, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24040478 ↗InjuryDec 30, 2025Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
InjuryNov 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23366464 ↗InjuryOct 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22080940 ↗InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K121787, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
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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