Mobi-C® Plug & Fit US MB3375Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03662663000093), received between Jul 9, 2019 and May 21, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO MOBI-C IMPLANTS DISASSEMBLED UPON INSERTION. DIFFERENT IMPLANTS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060968 ↗
• InjuryJan 8, 2025Migration; Migration

  IT WAS REPORTED THAT A MOBI-C REVISION SURGERY WAS PERFORMED TO ADDRESS POST-OP MIGRATION DUE TO A MOTOR VEHICLE ACCIDENT. THE MOBI-C WAS REMOVED AND CONVERTED TO AN ACDF.

  Patient problems: Insufficient Information

  MAUDE report 21104145 ↗
• InjuryFeb 13, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C DEVICES AFTER THE PATIENT WAS SHOWING SIGNS OF AN ALLERGIC REACTION. ALTHOUGH THE PATIENT IS NOT ALLERGIC TO NICKEL, AN ALLERGY TO THE MOBI-C WAS CONFIRMED WHEN THE DOCTOR TAPED A DEMO IMPLANT TO THE PATIENT'S ARM, AND WITHIN 30 MINUTES, THE SITE WAS TURNING RED AND ITCHING. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18699585 ↗
• InjuryNov 10, 2023Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  A PATIENT REPORTED THAT THEY HAVE TWO 5MM MOBI-C IMPLANTS, PLACED AT C5-C6 AND C6-C7, THAT ARE TOO BIG AND SITTING TOO ANTERIOR. THE PATIENT REPORTS THAT THEY ARE IN PAIN EVERY DAY AND ARE EXPERIENCING DYSPHAGIA. A SUCCESSFUL REVISION SURGERY WAS PERFORMED WHERE TWO 5MM TALL IMPLANTS WERE REPLACED WITH 4.5MM TALL IMPLANTS IN THE SAME FOOTPRINT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Dysphasia; Pain

  MAUDE report 18111903 ↗
• InjuryNov 10, 2023Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  A PATIENT REPORTED THAT THEY HAVE TWO 5MM MOBI-C IMPLANTS, PLACED AT C5-C6 AND C6-C7, THAT ARE TOO BIG AND SITTING TOO ANTERIOR. THE PATIENT REPORTS THAT THEY ARE IN PAIN EVERY DAY AND ARE EXPERIENCING DYSPHAGIA. A SUCCESSFUL REVISION SURGERY WAS PERFORMED WHERE TWO 5MM TALL IMPLANTS WERE REPLACED WITH 4.5MM TALL IMPLANTS IN THE SAME FOOTPRINT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Dysphasia; Pain

  MAUDE report 18111897 ↗
• InjuryJul 25, 2023Migration; Migration

  A PATIENT REPORTED THAT THE MOBILE CORE AND INFERIOR PLATE OF A MOBI-C IMPLANT WERE FOUND TO HAVE MIGRATED POST-OPERATIVELY AT LEVEL C6/7. A REVISION SURGERY WAS PERFORMED TO CONVERT THE PATIENT TO A FUSION.

  Patient problems: Subluxation

  MAUDE report 17389356 ↗
• InjuryDec 21, 2022Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C DEVICES AT LEVELS C5/6 AND C6/7. THE DEVICE AT C6/7 SUBSIDED, WENT INTO KYPHOSIS, AND CAUSED DISCOMFORT FOR THE PATIENT. THE SURGEON ADDED A FUSION CONSTRUCT ONCE THE MOBI-C DEVICES WERE REMOVED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Neck Pain

  MAUDE report 16023819 ↗
• InjuryDec 21, 2022Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C DEVICES AT LEVELS C5/6 AND C6/7. THE DEVICE AT C6/7 SUBSIDED, WENT INTO KYPHOSIS, AND CAUSED DISCOMFORT FOR THE PATIENT. THE SURGEON ADDED A FUSION CONSTRUCT ONCE THE MOBI-C DEVICES WERE REMOVED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Neck Pain

  MAUDE report 16023818 ↗
• InjuryDec 21, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT A MOBI-C DEVICE WAS REMOVED AT LEVEL C5/6 AND CONVERTED TO A FUSION BECAUSE THE REVISING SURGEON FELT THE IMPLANT INITIALLY INSTALLED WAS TOO SMALL FOR THE PATIENT AND WOULD HAVE INSERTED IT DEEPER/MORE POSTERIOR. THE FINAL FUSION CONSTRUCT EXTENDED FROM C5 TO T1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023420 ↗
• InjuryDec 8, 2022Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C IMPLANT WHOSE POLY CORE MIGRATED, CAUSING THE IMPLANT TO COLLAPSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Metal Related Pathology; Neck Pain

  MAUDE report 15940288 ↗
• InjurySep 8, 2021Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS DEVICE MIGRATION FOUND DURING A 6-WEEK POST-OPERATION FOLLOW-UP. BOTH MOBI-C DEVICES WERE REMOVED AND REPLACED BY A FUSION CONSTRUCT DURING THE REVISION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439570 ↗
• MalfunctionJul 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE MOBI-C IMPLANT MOVED WHEN THE SURGEON ATTEMPTED TO REMOVE THE PEEK CARTRIDGE. HOWEVER, PRODUCT EVALUATION BY A ZIMMER BIOMET EMPLOYEE FOUND THE MOBI-C IMPLANT TO BE DISASSEMBLED. THERE WAS NO REPORTED PATIENT HARM AND NO FURTHER SURGICAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10339164 ↗
• MalfunctionJul 18, 2019Disconnection; Detachment of Device or Device Component; Mechanical Jam; Disconnection; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT A MOBI-C IMPLANT WOULD NOT DISENGAGE FROM THE PEEK CARTRIDGE AFTER INSERTION. IT WAS THEN REMOVED FROM THE DISC SPACE AND DISASSEMBLED DURING REMOVAL. A DIFFERENT MOBI-C WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801549 ↗
• InjuryJul 9, 2019Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER THE IMPLANT MIGRATED POSTOPERATIVELY. AN ACDF WAS PREFORMED BUT NO FURTHER SURGICAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Information

  MAUDE report 8770953 ↗