Mobi-C Plug & Fit US MB3354Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663059053), received between Oct 15, 2024 and Oct 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE SURGEON BEGAN IMPLANTING THE MOBI-C IMPLANT, IT BECAME SEPARATED FROM THE INSERTER AND PEEK CARTRIDGE. WHEN HE REMOVED THE INSERTER THE PEEK CARTRIDGE WAS STILL INTACT WITH THE INNER PIN STILL CONNECTING EACH PEEK SIDE; HOWEVER, THE SURGEON OPTED NOT TO TRY TO REASSEMBLE IT. A DIFFERENT IMPLANT WAS USED AND THIS ONE WAS DISCARDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453901 ↗