CHS 71134060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010176448), received between Jan 10, 2020 and Jun 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT, A INT LAG RETAINING ROD WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640671 ↗
• MalfunctionJan 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT A DURING SURGERY A SMALL PIECE OF THE THREAD BROKE FROM THE ROD WHILE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED. THERE WAS NO DELAY AND NO INJURY REPORTED. BACKUP DEVICE FROM SMITH AND NEPHEW AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575501 ↗