SALVATION SEF20000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840420160478), received between Feb 14, 2022 and Oct 7, 2022 — classified as 3 injuries.

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

• InjuryOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EXTERNAL FIXATOR LOOSENED. THE PATIENT UNDERWENT A REVISION OF THE WIRES TO STABILIZE THE FIXATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567538 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ABSCESS/CELLULITIS SOMETIME POST-OP. THE PATIENT NEEDED TO HAVE I&D AND EXCHANGE OF INFECTED PINS ON THE EXTERNAL FIXATOR AND IV ANTIBIOTICS.

  Patient problems: Abscess; Cellulitis; Post Operative Wound Infection

  MAUDE report 13524517 ↗
• InjuryFeb 14, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE EXTERNAL FIXATOR HAD LOOSENED. THE WIRE WAS EXCHANGED TO TIGHTEN UP THE EXTERNAL FIXATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523596 ↗