BioHorizons PGREARecalls & reported problems
Biohorizons Implant Systems, Inc · Internal 4.5 Regular Emergence 3inOne Abutment · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847236005313), received between Jan 31, 2024 and Apr 30, 2026 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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
- Fracture9
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Fracture; Insufficient Device Problem Information
THIS REPORT COVERS THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25045010 ↗MalfunctionApr 29, 2026Fracture
THIS REPORT COVERS FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A BROKEN ABUTMENT . NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25035960 ↗MalfunctionApr 29, 2026Fracture
THIS REPORT COVERS FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A FRACTURE SCREW. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25035959 ↗MalfunctionJan 30, 2026Break
THIS REPORT INDICATES THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) HAVING A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24226170 ↗MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem
THIS REPORT SUMMARIZES SIX (6) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED THE ABUTMENT FRACTURED. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413692 ↗MalfunctionJul 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem
THIS REPORT INDICATES THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22683434 ↗InjuryMay 6, 2025Fracture; Fracture
MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZES SEVEN (7) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED ABUTMENT BREAKING OR BEING FRACTURED. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21937174 ↗InjuryApr 2, 2025Fracture; Fracture
MalfunctionMay 8, 2024Fracture; Fracture
InjuryFeb 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionJan 31, 2024Fracture; Fracture
THIS REPORT PROVIDES SEVEN (7) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED A REPORTED FRACTURED OR BROKEN OF THE REPORTED ITEM. NO PATIENT ADVERSE EVENT(S) WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18619549 ↗
Other Abutment, Implant, Dental, Endosseous devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.