BioHorizons PYSEARecalls & reported problems
Biohorizons Implant Systems, Inc · Internal 3.5mm Straight Esthetic Abutment · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847236006198), received between Mar 22, 2024 and Apr 29, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Insufficient Device Problem Information
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 25035983 ↗MalfunctionOct 29, 2025Fracture; Fracture
THIS REPORT INDICATES A SINGLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS AN EXPERIENCED A FRACTURE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23413468 ↗InjuryMar 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
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
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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