Mobi-C MB3795Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663002042), received between Feb 3, 2022 and Jul 26, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE INSERTION OF A MOBI-C IMPLANT, THE PEEK CARTRIDGE DISASSEMBLED AND RESULTED IN EARLY DEPLOYMENT OF THE DEVICE. RATHER THAN REBUILD AND REATTACH, THEY DECIDED TO USE ANOTHER IMPLANT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840842 ↗
• InjuryOct 19, 2023Migration; Migration

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C IMPLANT THAT MIGRATED POST-OPERATIVELY. ONE MONTH AFTER SURGERY, THE LOWER PLATE WAS PROLAPSED INTO THE SPINAL CANAL. THE REVISION WAS PERFORMED TO REPLACE THE MOBI-C IMPLANT WITH AN ACDF DEVICE EVEN THOUGH THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970076 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSERTION OF A MOBI-C IMPLANT, THE STOP PENETRATED PAST THE VERTEBRAL BODY WHICH LED TO THE IMPLANT BEING TOO POSTERIOR. THE SURGEON TRIED TO PULL THE IMPLANT OUT AND THE IMPLANT DISENGAGED. THERE WAS A 10-MINUTE DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102206 ↗
• MalfunctionJun 13, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT DEVELOPED OSTEOLYSIS AFTER A LEVEL MOBI-C PROCEDURE. THE SURGEON IS CURRENTLY MONITORING THIS PATIENT AND NO PLANS FOR REVISION HAVE BEEN IDENTIFIED AT THIS TIME. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 14676924 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INFERIOR ENDPLATE DETACHED FROM THE CARTRIDGE, CAUSING THE MOBI-C IMPLANT TO ROTATE INTO THE IMPROPER PLACEMENT. THE SURGEON REMOVED AND REPLACED THE IMPLANT WITHOUT A DELAY OR PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13445244 ↗