HOFFMANN 4934-4-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252611370), received between Oct 16, 2020 and Jun 20, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Crack; Crack

  AS REPORTED: "THE FRAMES WERE PREASSEMBLED AND STERILIZED. THE FRAMES WERE NOT USED IN THE CASE. AFTERWARDS, WHILE DISASSEMBLING THE FOOT RINGS CRACKED WHILE REMOVING THE FOOT ARCHES. CASE CANCELLED PRIOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161262 ↗
• MalfunctionJun 20, 2023Crack; Crack

  AS REPORTED: "THE FRAMES WERE PREASSEMBLED AND STERILIZED. THE FRAMES WERE NOT USED IN THE CASE. AFTERWARDS, WHILE DISASSEMBLING THE FOOT RINGS CRACKED WHILE REMOVING THE FOOT ARCHES. CASE CANCELLED PRIOR. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161249 ↗
• InjuryOct 16, 2020Fracture; Fracture

  AS REPORTED: "180MM CARBON FIBER FOOT PLATE LONG SNAPPED WHEN PATIENT WAS WALKING ON IT. WE HAD TO GO BACK FOR SURGERY A WEEK LATER. PATIENT SHOULD RECOVER JUST FINE, BUT HAD TO BE PUT UNDER ANESTHESIA AGAIN."

  Patient problems: Failure of Implant

  MAUDE report 10693737 ↗