BioHorizons PYHYBRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847236012120), received between May 3, 2023 and Sep 28, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fracture

  The Hybrid Base screw rounded.

  Patient problems: Insufficient Information

  MAUDE report 50913844 ↗
• InjurySep 28, 2026Manufacturing, Packaging or Shipping Problem

  Abutment screw loose.

  Patient problems: Insufficient Information

  MAUDE report 50913560 ↗
• MalfunctionApr 29, 2026Use of Device Problem

  THIS REPORT COVERS ONE (1) 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 25035974 ↗
• MalfunctionJan 30, 2026Use of Device Problem

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

  Patient problems: Insufficient Information

  MAUDE report 24223080 ↗
• InjuryDec 2, 2025Connection Problem; Connection Problem

  SCREW FAILURE IN TIBASE ABUTMENT.

  Patient problems: Insufficient Information

  MAUDE report 23697215 ↗
• MalfunctionJul 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  THIS REPORT INDICATES THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS A FRACTURED HEX. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22683433 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES FOUR (4) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED ABUTMENT FRACTURE. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21937173 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  THIS REPORT PROVIDES TWO (2) 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 18619557 ↗
• 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 16859955 ↗

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