BioHorizons PYMU173Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847236006716), received between Jan 31, 2023 and Oct 29, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Use of Device Problem; Connection Problem; Use of Device Problem; Connection Problem

  THIS REPORT SUMMARIZE ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED OF THE DEVICE(S) HAVING A CONNECTION ISSUE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23413541 ↗
• InjuryMar 26, 2024Fracture; Fracture

  THE SCREW FOR THEIR ANGLED MULTI-UNIT ABUTMENT AND POSSIBLY THE THREADING OF THE MUA ITSELF BROKE ON THE FINAL PROSTHESIS IN THE PATIENT'S MOUTH.

  Patient problems: Insufficient Information

  MAUDE report 18980576 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  THIS REPORT PROVIDES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED A BROKEN OR FRACTURED ITEM. NO PATIENT ADVERSE EVENT(S) WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18619525 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  THIS REPORT IS A SUMMARY OF 1 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 16859953 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

  THIS REPORT IS A SUMMARY OF TWO (2) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE WAS FRACTURED ISSUE. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16275275 ↗

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