BioHorizons TMR5810Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant RBT 5.8 x 10.5mm, 5.7 Platform · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons TMR5810 is a tapered, root-form dental implant used to anchor a replacement tooth in the jawbone. The 58 reports describe one recurring problem in almost all of them: the implant failing to fuse properly with the surrounding bone, along with a few reports of the implant fracturing. No deaths were reported and 58 injuries were. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00847236010379), received between Feb 15, 2024 and Aug 14, 2026 — classified as 57 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (54 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate54
- Use of Device Problem4
- Fracture1
Patient problems
- Insufficient Information57
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJun 29, 2026Failure to Osseointegrate
InjuryJun 26, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryApr 15, 2026Failure to Osseointegrate
InjuryMar 15, 2026Failure to Osseointegrate
InjuryMar 3, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24394495 ↗InjuryFeb 14, 2026Failure to Osseointegrate
InjuryFeb 12, 2026Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 15, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
InjuryOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, 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
- Z-1605-2015 · Apr 16, 2015 · TerminatedTapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page