NA 04.641.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034750491), received between Dec 19, 2017 and Dec 19, 2017 — classified as 1 malfunction.

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

• MalfunctionDec 19, 2017Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO DISTAL 220MM VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB II (VEPTR II) SIZE 4 AND SIZE 5 RODS BROKE WHEN THE SURGEON WAS BENDING THE RODS TO CONTOUR THEM AS PER THE SIZE OF THE PATIENT¿S RIB CAGE DURING A THORACIC SURGERY. THE PATIENT CAME IN FOR A PLANNED REVISION ON (B)(6) 2017 TO EXPAND AND ADJUST THE RODS. WHILE CONTOURING THE NEW RODS, THEY BROKE TOWARDS THE EXPANSION POINT WHERE IT CONVERTS TO THE RECTANGLE SHAPE. THE RODS BROKE WHEN THE SURGEON WAS BENDING IT WITH THE AID OF A ROD BENDER OUTSIDE THE PATIENT. THE BREAKAGE OCCURRED IN SITU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE HELP OF OTHER READILY AVAILABLE RODS FROM THE SETS. THERE WAS 60 MINUTES OF SURGICAL DELAY REPORTED TO COMPLETE THE PROCEDURE AND THE PATIENT OUTCOME WAS REPORTED TO BE FINE. LATERAL RIB HOOK AND DISTAL 220 ROD WAS EXPLANTED DURING HARDWARE REMOVAL. CONCOMITANT DEVICE (S) REPORTED: ROD BENDER (UNKNOWN PART AND LOT NUMBER, UNKNOWN QUANTITY). THIS REPORT IS FOR ONE (1) TI DISTAL EXTENSION SIZE 4/220MM RADIUS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129424 ↗

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