BioHorizons PGSEARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847236005399), received between Jan 31, 2023 and Apr 29, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Insufficient Device Problem Information

  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 25035958 ↗
• 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 25035957 ↗
• MalfunctionJan 30, 2026Use of Device Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 24226117 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  THIS REPORT INDICATES A SINGLE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED OF THE DEVICE(S) HAS AN EXPERIENCED A FRACTURE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23413554 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES THREE (3) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED ABUTMENT BREAKING OR BEING FRACTURED. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21937182 ↗
• 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 18619551 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 16275279 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 16275263 ↗

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