NA 03.641.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034720142), received between Jan 26, 2017 and Jan 26, 2017 — classified as 1 malfunction.

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. 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.

• MalfunctionJan 26, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A UNILATERAL VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR II) SYSTEM ON AN UNKNOWN DATE, UNDERWENT A SIMPLE VEPTR DISTRACTION ON (B)(6) 2017. HOWEVER, IT WAS KNOWN PREOPERATIVELY THAT THE RIB HOOK HAD PULLED LOOSE. THE SURGEON REPLACED THE RIB HOOK, EXTENDED IT ANOTHER LEVEL FROM T4 TO T3 WITH A RIB HOOK EXTENSION AND REPLACED THE PROXIMAL EXTENSION. IT WAS REPORTED THAT THE FINAL X-RAY CONFIRMED GOOD FIXATION. DURING THE SURGERY, AS THE SURGEON WAS USING THE CAP HOLDING FORCEPS, A SMALL PIECE OF THE TIP BROKE OFF. IT WAS CONFIRMED BY STANDARD X-RAY THAT THE FRAGMENT WAS RETRIEVED. IT WAS REPORTED THAT THE BROKEN INSTRUMENT WAS HANDED OFF THE STERILE FIELD AND THE SURGERY PROCEEDED WITHOUT FURTHER INCIDENT OR DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. THIS COMPLAINT ADDRESSES THE BROKEN INSTRUMENT. THE REVISION SURGERY IS BEING CAPTURED IN LINKED COMPLAINT COM-(B)(4). CONCOMITANT DEVICES: VEPTR RIB HOOK (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), VEPTR RIB HOOK EXTENSION (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), VEPTR PROXIMAL EXTENSION (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6279269 ↗