HOFFMANN 5048-5-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540492913), received between Dec 20, 2022 and Apr 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "HOFFMAN COMPACT MRI WAS USED ON THE FIRST METATARSAL FOOT AT THE PRIMARY SURGERY (B)(6) 2024. THE ROD WAS EXTENDED TO THE TIBIA AND FIXED. ON (B)(6) 2024, THE ROD WAS BROKEN NEAR THE MIDDLE DUE TO THE PATIENT'S FALL. THE ROD IS SCHEDULED TO BE REPLACED WITH A NEW ONE ON (B)(6) 2024 AT THE HOSPITAL WARD."

  Patient problems: Fall

  MAUDE report 19039511 ↗
• InjuryDec 20, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF A HOFFMANN FIXATOR ROD ALREADY IN PLACE ON THE PATIENT'S FOOT 4 DAYS AFTER APPLICATION (APPLICATION (B)(6) 2022). FRACTURE DIRECTLY AT THE CONNECTOR. ROD HAD TO BE REPLACED IN REVISION SURGERY ON (B)(6) 2022."

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16017979 ↗