BioHorizons PYMU172Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847236006709), received between Jan 31, 2023 and Apr 29, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 25035970 ↗
• MalfunctionJan 30, 2026Use of Device Problem

  THIS REPORT INDICATES TWO (2) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) HAVING A FRACTURED ABUTMENT SCREW OR ABUTMENT. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24226162 ↗
• MalfunctionJul 31, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT INDICATES TWO (2) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) BEING STRIPPED. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22682579 ↗
• MalfunctionApr 30, 2025Connection Problem; Connection Problem

  THIS REPORT SUMMARIZE THREE (3) MALFUNCTION EVENT(S). A REVIEW OF THE EVENTS INVOLVED OF THE DEVICE(S) WITH CONNECTION ISSUES. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21937172 ↗
• InjuryApr 11, 2024Fracture; Fracture

  TM SBORDER REPORTS THAT THIS ABUTMENT IS BROKEN. RA SENT TO RETURN PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 19088977 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  THIS REPORT IS A SUMMARY OF 7 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 16859954 ↗
• MalfunctionJan 31, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THIS REPORT IS A SUMMARY OF ONE (1) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE WAS STRIPPED. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16275274 ↗

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, Classified
  Temporary Titanium Abutments