BioHorizons PGTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847236005436), received between May 3, 2023 and Jul 31, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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.

• MalfunctionJul 31, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50098571 ↗
• MalfunctionApr 29, 2026Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 25035964 ↗
• 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 25035963 ↗
• InjuryFeb 9, 2026Fracture

  ABUTMENT HAS BROKEN OFF AT THE HEX.

  Patient problems: Insufficient Information

  MAUDE report 24291375 ↗
• MalfunctionJul 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  THIS REPORT INDICATES TWO (2) 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 22683435 ↗
• InjuryMar 6, 2024Fracture; Fracture

  BROKEN HEX ON ABUTMENTS.

  Patient problems: Insufficient Information

  MAUDE report 18848488 ↗
• 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 18619523 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  THIS IS A SUMMARY REPORT FOR TWO (2) MALFUNCTION EVENT(S). A REVIEW OF THE EVENT INVOLVED THE ABUTMENT FRACTURED. 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 17431577 ↗
• MalfunctionMay 3, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem

  THIS REPORT IS A SUMMARY OF 3 MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE EXPERIENCING A BROKEN ABUTMENT OR ABUTMENT HEX. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16859951 ↗

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