EXPEDIUM VERSE 199723755SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034444482), received between Nov 28, 2018 and Oct 16, 2023 — classified as 2 injuries.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REP WAS CONTACTED BY SURGEON¿S OFFICE STAFF ON (B)(6) 2023 REQUESTING THE METAL COMPOSITION FOR IMPLANTS USED ON A PATIENT. THE REP EMAILED THE SURGEON AND HIS STAFF DIRECTLY AFTER BEING CONTACTED. HE PROVIDED THEM WITH THE REQUESTED INFORMATION FOR EXPEDIUM AND -METAL COMPOSITION BREAKDOWNS. THEY SAID THE PATIENT WAS EXPERIENCING SWELLING, REDNESS AND IRRITATION IN HIS ABDOMEN. POTENTIALLY MAY BE HAVING A REACTION TO THE IMPLANTS. HE WAS CONTACTED AGAIN BY SURGEON¿S OFFICE THIS AFTERNOON. THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND SURGEON¿S OFFICE ASKED IF WE COULD PROVIDE "PATCH TEST KIT¿. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 7.0X55 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17940606 ↗
• InjuryNov 28, 2018Break; Break

  THE FOLLOWING WAS REPORTED: DEFECTIVE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112024 ↗