Mobi-C® Plug & Fit US MB3556Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663000079), received between Jun 26, 2019 and Sep 3, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS RADICULOPATHY CAUSED BY A POST-OP MOBI-C CORE FRACTURE AT C5/C6. THE SUPERIOR ENDPLATE HAD ALSO SHIFTED FORWARD TO WHERE IT WAS 2-3MM PROUD OF THE VERTEBRAL BODY. THE IMPLANT WAS REMOVED AND CONVERTED TO ACDF USING COMPETITIVE PRODUCT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 22956704 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT BOTTOM ENDPLATE DETACHED FROM THE PEEK WHILE IMPLANTING AND IMPACTING. ANOTHER MOBI-C IMPLANT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477460 ↗
• MalfunctionJul 29, 2019Disconnection; Failure to Disconnect; Disconnection; Failure to Disconnect

  IT WAS REPORTED THAT DURING SURGERY, UPON INSERTING THE IMPLANT, THERE WAS DIFFICULTY RELEASING THE IMPLANT FROM THE CARTRIDGE. THE PEEK CARTRIDGE WAS REMOVED AND IT WAS FOUND THAT THE TOP ENDPLATE WAS TWISTED. THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS USED IN ITS PLACE. THERE WAS NO PATIENT OR SURGICAL EFFECT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8835336 ↗
• MalfunctionJul 16, 2019Disconnection; Malposition of Device; Detachment of Device or Device Component; Disconnection; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT CAME OFF ITS RETENTION FEATURE DURING REPOSITIONING BY THE SURGEON THE IMPLANT WAS REPLACED WITH A ALTERNATE IMPLANT TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8792502 ↗
• MalfunctionJun 26, 2019Loose or Intermittent Connection; Device Handling Problem; Loose or Intermittent Connection; Device Handling Problem

  IT WAS REPORTED THAT DURING SURGERY, THE MOBI-C IMPLANT WAS LOOSE ON THE PEEK CARTRIDGE HOLDING IT. AS SUCH, A DIFFERENT IMPLANT WAS USED IN ITS PLACE. NO SURGICAL IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8735429 ↗