BioHorizons PYMU2Recalls & reported problems
Biohorizons Implant Systems, Inc · 3.5mm Multi-unit Abutment, Straight 2mm Collar · Class 2 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847236006730), received between Oct 31, 2022 and Apr 29, 2026 — classified as 3 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
- Incomplete or Inadequate Connection1
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- Insufficient Information10
Recent adverse event reports
The 10 most recent of 10 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 OPERATIONAL ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25035973 ↗MalfunctionOct 29, 2025Fracture; Fracture
THIS REPORT INDICATES A SINGLE (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 23413549 ↗MalfunctionJul 31, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THIS REPORT SUMMARIZE TWO (2) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED OF THE DEVICE(S) EXPERIENCING AN ENGAGEMENT ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22682578 ↗MalfunctionApr 30, 2025Fracture; Fracture
THIS REPORT SUMMARIZE ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) FRACTURING. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21940060 ↗InjuryJan 16, 2025Fracture; Fracture
InjuryOct 11, 2024Fracture; Fracture
InjuryJun 25, 2024Fracture; Fracture
ABUTMENT SCREW STUCK INSIDE THE MULTI-UNIT PART AND WAS FRACTURED.
Patient problems: Insufficient Information
MAUDE report 19606231 ↗MalfunctionMay 3, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF 5 MALFUNCTION EVENT(S). A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN ABUTMENT OR STRIPPED. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16859956 ↗MalfunctionJan 31, 2023Fracture; Fracture
THIS REPORT IS A SUMMARY OF FOUR (4) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN HEX. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16275277 ↗MalfunctionOct 31, 2022Use of Device Problem; Use of Device Problem
THIS REPORT PROVIDES A SUMMARY OF ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED A REPORTED ABUTMENT STRIPPING DURING USAGE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15704367 ↗
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.