Mobi-C® Plug & Fit US MB3577Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663000178), received between Sep 7, 2021 and Mar 6, 2023 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C LOWER PLATE AND POLY CORE DISLODGED FROM THE IMPLANT CARTRIDGE WHILE IT WAS BEING MALLETED INTO THE DISC SPACE. THE PIECES WERE RECOVERED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MOBI-C IMPLANT. THERE WAS A DELAY OF 10 MINUTES WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484844 ↗
• InjurySep 7, 2021Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE TWO MOBI-C IMPLANTS THAT WERE NOT ORIGINALLY PLACED PROPERLY AND WERE OVERSIZED, AND WERE CAUSING THE PATIENT PAIN. THEY WERE REPLACED WITH ALTERNATIVE DISC REPLACEMENTS WITH SMALLER FOOTPRINTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 12436037 ↗