BioHorizons PYMU303Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847236006754), received between May 3, 2023 and Apr 29, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Use of Device Problem

  THIS REPORT COVERS FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) EXPERIENCING A STRIPPED ABUTMENT. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25035976 ↗
• MalfunctionOct 29, 2025Connection Problem; Connection Problem

  THIS REPORT INDICATES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) BEING FRACTURED. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23415136 ↗
• MalfunctionOct 29, 2025Damaged Thread; Damaged Thread

  THIS REPORT INDICATES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE DEVICE(S) BEING FRACTURED. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23414170 ↗
• MalfunctionOct 29, 2025Inadequate User Interface; Inadequate User Interface

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

  Patient problems: Insufficient Information

  MAUDE report 23414169 ↗
• MalfunctionJul 31, 2025Connection Problem; Connection Problem

  THIS REPORT SUMMARIZES THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED FITTING ISSUE TO ANOTHER DEVICE. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22682581 ↗
• 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 ENGAGEMENT ISSUES. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21937167 ↗
• InjuryJan 16, 2025Fracture; Fracture

  ABUTMENT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21171703 ↗
• InjuryJun 28, 2024Fracture; Fracture

  ABUTMENT WASN'T SEATING PROPERLY ON IMPLANT. USED ANOTHER ABUTMENT TO FINISH PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19631983 ↗
• MalfunctionJan 31, 2024Connection Problem; Connection Problem

  THIS REPORT PROVIDES TWO (2) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED A CONNECTION ISSUE FOR THE REPORTED ITEM. NO PATIENT ADVERSE EVENT(S) WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18619558 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  THIS REPORT PROVIDES THREE (3) 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 18619556 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  THIS REPORT IS A SUMMARY OF 2 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 16859957 ↗

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