NA 497.134Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034787565), received between Mar 16, 2018 and Mar 16, 2018 — classified as 1 injury.

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.

• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL PROCEDURE PERFORMED ON (B)(6) 2018; DURING REMOVAL AND PLACEMENT OF IMPLANTS IN THE [SPINAL] COLUMN, IT WAS OBSERVED DURING THE PROCEDURE THAT THE PATIENT HAD METALLOSIS IN THE SPINE CAUSED BY THE [PREVIOUSLY IMPLANTED] VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) IMPLANTS DOCUMENTED AS A LUMBAR EXTENSION ROD AND A TITANIUM RIB SLEEVE (OR EXTENSION BAR). WASHING AND DEBRIDEMENT OF THE SOFT TISSUE WERE PERFORMED. ARTHRODESIS WAS PERFORMED WITH EXPEDIUM [GROWING SPINE SYSTEM IMPLANTS]. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. IT IS UNKNOWN IF THERE WERE ADDITIONAL DEVICES IMPLANTED TO SUPPORT THE VEPTR RODS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) TI LUMBAR EXTENSION SIZE 9/220MM RADIUS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7346102 ↗

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