BioHorizons PGCMAVRecalls & reported problems
Biohorizons Implant Systems, Inc · 4.5mm Custom Milled Abutment, Vulcan · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00847236021696), received between Jan 31, 2023 and Jul 31, 2026 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (20 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
- Fracture20
- Use of Device Problem5
- Break1
Patient problems
- Insufficient Information21
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50098567 ↗InjuryMay 15, 2026Fracture
InjuryMay 8, 2026Fracture
MalfunctionApr 30, 2026Fracture; Use of Device Problem
THIS REPORT COVERS THIRTEEN (13) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCED A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25045072 ↗MalfunctionJan 30, 2026Break; Use of Device Problem
THIS REPORT INDICATES FOURTEEN (14) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) HAVING A FRACTURED BROKEN HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24225203 ↗MalfunctionOct 29, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem
THIS REPORT SUMMARIZES EIGHT (8) 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 23413700 ↗MalfunctionJul 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem
THIS REPORT INDICATES FOUR (4) 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 22683438 ↗MalfunctionJul 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem
THIS REPORT INDICATES FOUR (4) 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 22683437 ↗MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 33 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 21937193 ↗InjuryJan 10, 2025Fracture; Fracture
InjuryJan 7, 2025Fracture; Fracture
InjuryJan 7, 2025Fracture; Fracture
InjurySep 13, 2024Fracture; Fracture
InjurySep 13, 2024Fracture; Fracture
InjuryJun 11, 2024Fracture; Fracture
MalfunctionMay 10, 2024Fracture; Fracture
MalfunctionFeb 29, 2024Fracture; Fracture
InjuryFeb 24, 2024Fracture; Fracture
HEX FRACTURE VULCAN COMPLAINT # (B)(4).
Patient problems: Insufficient Information
MAUDE report 18774058 ↗MalfunctionJul 31, 2023Fracture; Fracture
THIS IS A SUMMARY REPORT FOR TWO (2) MALFUNCTION EVENT(S). A REVIEW OF THE EVENT INVOLVED THE ABUTMENT FRACTURED. THE REPORT WAS RECEIVED WITH NO PATIENT ADVERSE EVENT(S) BEING REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17431579 ↗MalfunctionJul 31, 2023Fracture; Fracture
THIS IS A SUMMARY REPORT FOR ONE (1) MALFUNCTION EVENT(S). A REVIEW OF THE EVENT INVOLVED THE ABUTMENT FRACTURED. THE REPORT WAS RECEIVED WITH NO PATIENT ADVERSE EVENT(S) BEING REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17431574 ↗MalfunctionJan 31, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF THREE (3) 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 16275255 ↗
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.