BioHorizons PGCAHRecalls & reported problems
Biohorizons Implant Systems, Inc · Internal 4.5mm Custom Cast Abutment, Hexed · Class 2 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847236005078), received between May 3, 2023 and Apr 30, 2026 — classified as 7 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 reports).
1 other recall cover devices cleared under the same FDA submission (K103691, 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
- Fracture15
- Use of Device Problem1
Patient problems
- Insufficient Information15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2026Fracture; Use of Device Problem
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 25045051 ↗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 25036001 ↗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 25035946 ↗InjuryJan 25, 2026Fracture
MalfunctionOct 29, 2025Fracture; Fracture
THIS REPORT INDICATES A SIGNLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS A EXPERIENCED A FRACTURE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413567 ↗MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZES THREE (3) 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 21937184 ↗InjuryApr 1, 2025Fracture; Fracture
InjuryJul 18, 2024Fracture; Fracture
InjuryMay 9, 2024Fracture; Fracture
InjuryApr 29, 2024Fracture; Fracture
InjuryMar 13, 2024Fracture; Fracture
InjuryMar 7, 2024Fracture; Fracture
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 18619550 ↗MalfunctionJul 31, 2023Fracture; Fracture
THIS IS A SUMMARY REPORT FOR SIX (6) 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 17431575 ↗MalfunctionMay 3, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF ELEVEN (11) 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 16859945 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103691, 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.