Mobi-C® Plug & Fit US MB9001RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03662663000741), received between Apr 16, 2020 and Sep 18, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE METAL KNOB ON A MOBI-C INSERTION HANDLE BROKE OFF. THE IMPLANT HAD ALREADY BEEN INSERTED AND THERE WAS NO PATIENT HARM OR PROCEDURAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084185 ↗
• InjuryMay 6, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C5-C6 ANTERIOR CERVICAL SPINE DECOMPRESSION DISCECTOMY WITH PLANS TO UTILIZE THE MOBI-C ARTIFICIAL CERVICAL DISC REPLACEMENT. AS THE SURGEON ATTEMPTED TO CAREFULLY INTRODUCE THE PROTHESIS, THE UNIVERSAL INSERTER (IMPLANT INSERTER) FAILED, CAUSING THE PROTHESIS TO BE PUSHED PAST THE POSTERIOR WALL OF THE VERTEBRAL BODY AND COMPRESSING THE SPINAL CORD. THE PROTHESIS WAS REMOVED FROM THE DISC SPACE AND A COMPETITIVE INTERBODY CAGE WAS UTILIZED INSTEAD. THE PATIENT IS NOW PARTIALLY PARALYZED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 21969354 ↗
• MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A MOBI-C IMPLANT HOLDER BROKE WHILE RELEASING THE CAGE. THE INCIDENT OCCURRED INTRA-OPERATIVELY, BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055403 ↗
• MalfunctionOct 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE KNOB BROKE OFF A MOBI-C INSERTER INTRA-OPERATIVELY. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606008 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THE SURGEON WAS IMPLANTING MOBI-C WITHOUT DISTRACTION AND THE INSERTER BROKE WHEN THE SURGEON MALLETED VERY HARD ON IT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316016 ↗
• InjuryApr 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE KNOB OF THE IMPLANT HOLDER BROKE OFF WHILE THE SURGEON WAS ATTEMPTING TO REMOVE IT FROM THE IMPLANT. THERE WAS A GREATER THAN 30 MINUTE DELAY WHILE THE SURGEON REMOVED THE BROKEN IMPLANT HOLDER. THERE WAS NO ADDITIONAL REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9969854 ↗