Mobi-C® Plug & Fit US MB3356Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663000017), received between Dec 29, 2020 and Mar 28, 2024 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE MOBI-C IMPLANT DISASSEMBLED IN THE DISC SPACE DURING INSERTION. IT WAS REMOVED AND ANOTHER IMPLANT WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001113 ↗
• 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 ONE OF TWO FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 12436021 ↗
• InjuryDec 29, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS DEVICE MIGRATION. THE INITIALLY IMPLANTED MOBI-C DEVICE WAS REMOVED. A SECOND MOBI-C DEVICE WAS INSTALLED, BUT THE SURGEON REMOVED IT BECAUSE IT WAS NOT ALIGNED PROPERLY IN THE DISC SPACE BECAUSE OF EITHER A VERTEBRAL BODY DEFECT OR AGGRESSIVE DRILLING OF THE ENDPLATE. THE SURGEON DECIDED TO INSTALL A FUSION CONSTRUCT INSTEAD OF THE MOBI-C DEVICE AT THAT LEVEL.

  Patient problems: Failure of Implant; No Information

  MAUDE report 11089938 ↗