BioHorizons PYCMAVRecalls & reported problems
Biohorizons Implant Systems, Inc · 3.5mm Custom Milled Abutment, Vulcan · Class 2 · Implant
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847236021702), received between Jan 31, 2023 and Jul 31, 2026 — classified as 5 injuries, 8 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
- Break1
- Connection Problem1
- Manufacturing, Packaging or Shipping Problem1
- Misconnection1
Patient problems
- Insufficient Information13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50098570 ↗InjuryMay 21, 2026Manufacturing, Packaging or Shipping Problem
MalfunctionApr 30, 2026Fracture
THIS REPORT COVERS SEVEN (7) 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 25045050 ↗InjuryFeb 13, 2026Fracture
MalfunctionJan 30, 2026Break; Misconnection
THIS REPORT INDICATES SIX (6) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) HAVING A FRACTURED BROKEN HEXAND CONNECTION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24225202 ↗MalfunctionOct 29, 2025Fracture; Fracture
THIS REPORT INDICATES ELEVEN (11) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) BEING FRACTURED. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413694 ↗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 22683440 ↗MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZES TEN (10) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED ABUTMENT FRACTURE. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21937162 ↗InjuryMar 25, 2024Fracture; Fracture
InjuryMar 7, 2024Use of Device Problem; Use of Device Problem
InjuryFeb 24, 2024Fracture; Fracture
MalfunctionJan 31, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF TWO (2) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN ABUTMENT OR ABUTMENT HEX. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16275272 ↗MalfunctionJan 31, 2023Connection Problem; Connection Problem
THIS REPORT IS A SUMMARY OF ONE (1) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING CONNECTION ISSUES. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16275270 ↗
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.