O-Ring 1700554Recalls & reported problems
Preat Corporation · O-Ring Ball Abutment BioHorizons 4.5mm x 4mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816577023829), received between Jul 13, 2026 and Jul 13, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 reports).
3 other recalls cover devices cleared under the same FDA submission (K183518); 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 Osseointegrate3
- Loss of Osseointegration1
Patient problems
- Failure of Implant4
- Unspecified Infection2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25807970 ↗InjuryJul 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25807968 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AN INFECTION WAS ALSO REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25807967 ↗InjuryJul 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PATIENT ALSO REPORTED AN INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25807802 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183518. One submission often covers many models, so check the product and lot details in each record.
- Z-2514-2025 · Jun 25, 2025 · Open, ClassifiedNobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
- Z-1987-2025 · Apr 2, 2025 · Open, ClassifiedBiomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary
- Z-1321-2024 · Feb 9, 2024 · Open, ClassifiedPreat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Other Abutment, Implant, Dental, Endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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.
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