BioHorizons PYMU1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847236006693), received between Jan 31, 2023 and Sep 21, 2026 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Failure to Osseointegrate

  Abutment stripped.

  Patient problems: Insufficient Information

  MAUDE report 50836128 ↗
• MalfunctionApr 30, 2026Fracture; Use of Device Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 25045076 ↗
• MalfunctionApr 29, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  THIS REPORT COVERS TWO (2) 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 25035994 ↗
• MalfunctionJan 30, 2026Material Separation

  THIS REPORT INDICATES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) EXPERIENCING ABUTMENT STUCK INSIDE IMPLANT. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24227172 ↗
• MalfunctionJan 30, 2026Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 24226897 ↗
• MalfunctionOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 23413691 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 23413671 ↗
• MalfunctionApr 30, 2025Crack; Crack

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

  Patient problems: Insufficient Information

  MAUDE report 21940068 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  THIS IS A SUMMARY REPORT FOR TWO (2) MALFUNCTION EVENT(S). A REVIEW OF THE EVENT INVOLVED THE ABUTMENT NO SEATING PROPERLY. THE REPORT WAS RECEIVED WITH NO PATIENT ADVERSE EVENT(S) BEING REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17431573 ↗
• MalfunctionJan 31, 2023Connection Problem; Connection Problem

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

  Patient problems: Insufficient Information

  MAUDE report 16275273 ↗

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