BioHorizons PGCMARecalls & reported problems
Biohorizons Implant Systems, Inc · 4.5mm Custom Milled Abutment · Class 2 · Implant
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847236012090), received between Jan 31, 2023 and Apr 30, 2026 — classified as 8 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (13 reports).
1 other recall cover devices cleared under the same FDA submission (K151621, 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
- Fracture13
- No Apparent Adverse Event3
- Use of Device Problem2
- Break1
Patient problems
- Insufficient Information17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Fracture; Use of Device Problem
THIS REPORT COVERS FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCED A FRACDTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25045068 ↗InjuryFeb 17, 2026Fracture
MalfunctionJan 30, 2026Break; Use of Device Problem
THIS REPORT INDICATES FIVE (5) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) HAVING A FRACTURED ABUTMENT HEX OR BROKEN SCREW. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24225306 ↗InjuryJan 7, 2026Fracture
MalfunctionOct 29, 2025Fracture; Fracture
THIS REPORT SUMMARIZES FIVE (5) 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 23413696 ↗MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZES FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED ABUTMENT HEX BREAKING OR BEING FRACTURED. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21937195 ↗InjuryOct 25, 2024Fracture; Fracture
HEX FRACTURE - VULCAN COMPLAINT# (B)(4).
Patient problems: Insufficient Information
MAUDE report 20534813 ↗InjuryJun 18, 2024Fracture; Fracture
MalfunctionJun 3, 2024Fracture; Fracture
MalfunctionMay 13, 2024No Apparent Adverse Event; No Apparent Adverse Event
MalfunctionMay 10, 2024Fracture; Fracture
MalfunctionMay 10, 2024Fracture; Fracture
InjuryMar 8, 2024Fracture; Fracture
InjuryMar 8, 2024Fracture; Fracture
InjuryFeb 24, 2024No Apparent Adverse Event; No Apparent Adverse Event
HEX FRACTURED. VULCAN COMPLAINT # - (B)(4).
Patient problems: Insufficient Information
MAUDE report 18774226 ↗InjuryFeb 24, 2024No Apparent Adverse Event; No Apparent Adverse Event
HEX FRACTURED. VULCAN COMPLAINT # (B)(4). VULCAN HAS SENT REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 18774212 ↗MalfunctionJan 31, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF SIX (6) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN HEX OR ABUTMENT. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16275259 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K151621, 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 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.