BioHorizons PXMUASRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847236006532), received between Oct 31, 2022 and Apr 30, 2026 — classified as 1 injury, 12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 25045096 ↗
• MalfunctionApr 29, 2026Use of Device Problem

  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 25036002 ↗
• MalfunctionJan 30, 2026Break

  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 24225142 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED THE ABUTMENT SCREW FRACTURED. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23413695 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INVOLVED THE ABUTMENT SCREW BINDING WITHIN ANOTHER DEVICE. NO PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23413693 ↗
• MalfunctionJul 31, 2025Use of Device Problem; Use of Device Problem

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

  Patient problems: Insufficient Information

  MAUDE report 22682582 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

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

  Patient problems: Insufficient Information

  MAUDE report 21937179 ↗
• InjuryFeb 24, 2024Fracture; Fracture

  ABUTMENT KEEPS DEFORMING.

  Patient problems: Insufficient Information

  MAUDE report 18773937 ↗
• MalfunctionJan 31, 2024Fracture; Fracture

  THIS REPORT PROVIDES TWO (2) 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 18619552 ↗
• MalfunctionMay 3, 2023Fracture; Fracture

  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 16859949 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

  THIS REPORT IS A SUMMARY OF SIXTEEN (16) MALFUNCTION EVENTS. A REVIEW OF THE EVENT(S) INVOLVED A DEVICE WAS FRACTURED ISSUE. NO ADVERSE EVENT PATIENT INFORMATION WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16275266 ↗
• MalfunctionOct 31, 2022Use of Device Problem; Use of Device Problem

  THIS REPORT SUMMARIZE ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED AN ABUTMENT UNABLE TO INSERT INTO IMPLANT. ZERO (0) PATIENT ADVERSE EVENTS WERE REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15705055 ↗
• MalfunctionOct 31, 2022Use of Device Problem; Use of Device Problem

  THIS REPORT PROVIDES A SUMMARY OF ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INVOLVED THE REPORTED ABUTMENT SCREW STRIPPED DURING USAGE. NO PATIENT ADVERSE EVENT WAS REPORTED. NO INFORMATION REGARDING PATIENT DEMOGRAPHICS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15705048 ↗

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