NA 04.601.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034734231), received between Dec 27, 2017 and Dec 27, 2017 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K142587); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2017Break; Break

  IT WAS NOTED THE PATIENT WAS STABLE FOLLOWING SURGERY. INITIALLY IT WAS REPORTED THE PELVIC HOOK FRACTURED INTO PIECES THAT WERE DIFFICULT TO REMOVE. DURING THE INVESTIGATION IT WAS NOTED IT WAS ALSO FOUND TO BE BENT AND HAS NICKS AND GOUGES ACROSS THE BALANCE OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 7148579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142587. One submission often covers many models, so check the product and lot details in each record.

• Z-2488-2015 · Jul 29, 2015 · Terminated
  VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic de