EF1 DNE-9000-UJRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810028397101), received between Apr 29, 2025 and Apr 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 2, 2025Open, Classified

   Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

   Z-2513-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  COMPLAINT - DEVICE BROKE POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931589 ↗
• MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  COMPLAINT: DEVICE BROKE POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931581 ↗
• MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  COMPLAINT - DEVICE BROKE POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931579 ↗