Mobi-C® Plug & Fit US MB3355Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03662663000000), received between May 2, 2019 and Jan 6, 2026 — classified as 18 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Migration

  IT WAS REPORTED THAT A MOBI-C PATIENT PRESENTED WITH NECK PAIN, HEADACHES, AND BILATERAL ARM NUMBNESS APPROXIMATELY ONE YEAR POST-OPERATIVELY. IMAGES WERE TAKEN WHICH SHOWED THAT THE IMPLANT'S INFERIOR ENDPLATE AND CORE DISLODGED AND MIGRATED WELL BEYOND THE POSTERIOR BORDER OF THE PATIENT'S VERTEBRAL BODY AND INTO THE FORAMEN/SPINAL CANAL. A REVISION SURGERY WAS PERFORMED TO SAFELY REMOVE THE IMPLANT AND REPLACE WITH AN ACDF.

  Patient problems: Headache; Neck Pain; Numbness

  MAUDE report 23975765 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INSERTION, A MOBI-C IMPLANT DISASSEMBLED IN THE DISC SPACE. ALL COMPONENTS WERE RETRIEVED AND THE SURGERY WAS COMPLETED USING ANOTHER IMPLANT WITHOUT ANY DELAYS OR PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462280 ↗
• MalfunctionOct 31, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER A MOBI-C IMPLANT WAS IMPLANTED, IMAGING SHOWED THAT THE INFERIOR PLATE WAS MISALIGNED. IT IS CURRENTLY UNKNOWN WHETHER THE IMPLANT WAS REVISED OR IF IT REMAINS IMPLANTED. THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579388 ↗
• InjurySep 23, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ONE MONTH POST-OPERATIVELY TO REMOVE A MOBI-C AND CONVERT TO AN ACDF. THE DEVICE HAD BEEN SPLAYED OPEN A BIT ON ONE SIDE AND HAD DISTRACTED THE FACET LEADING TO RECURRENT SYMPTOMS AND NECK PAIN.

  Patient problems: Neck Pain

  MAUDE report 20279054 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED WHILE IMPLANTING. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075551 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MOBI-C PATIENT HAD HYPERMOBILITY AND DEVELOPED CORD SIGNAL CHANGE WITH MYELOPATHY AT THE ARTHROPLASTY LEVELS C4/5 AND C5/6. A REVISION SURGERY WAS PERFORMED TO REMOVE THE MOBI-C DEVICES. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 18066341 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MOBI-C PATIENT HAD HYPERMOBILITY AND DEVELOPED CORD SIGNAL CHANGE WITH MYELOPATHY AT THE ARTHROPLASTY LEVELS C4/5 AND C5/6. A REVISION SURGERY WAS PERFORMED TO REMOVE THE MOBI-C DEVICES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Joint Laxity; Nerve Damage

  MAUDE report 18066323 ↗
• InjuryNov 3, 2023Migration; Migration

  IT WAS REPORTED THAT A MOBI-C DEVICE AT C5/6 MIGRATED AND LED TO DISABILITY AND WORSENING RADICULOPATHY IN A PATIENT. THE PATIENT IS UNDER OBSERVATION AND NO TREATMENTS HAVE BEEN PERFORMED TO DATE.

  Patient problems: Neuralgia

  MAUDE report 18065133 ↗
• InjurySep 8, 2023Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C IMPLANTS AND CONVERT TO A FUSION. THE PATIENT'S RADICULAR SYMPTOMS RETURNED AND THE REVISING SURGEON FELT THE IMPLANTS WERE IMPROPERLY SIZED AND IMPLANTED, AND THE LEVELS WERE NOT FULLY DECOMPRESSED. THE MOBI-C DEVICES WERE INSTALLED APPROXIMATELY FOUR YEARS AGO. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 17715410 ↗
• InjuryJul 25, 2023Fracture; Malposition of Device; Fracture; Malposition of Device

  IT WAS REPORTED THAT A MOBI-C DEVICE WAS REMOVED AFTER THE PATIENT DEVELOPED POST-OPERATIVE NECK, SHOULDER, AND ARM SYMPTOMS, KYPHOSIS, AND THE IMPLANT BROKE AT LEVEL C6/7. DURING THE REVISION, THE SUPERIOR END PLATE WAS FOUND TO BE DISPLACED AND WAS NOT WELL-FIXED. THE MOBI-C DEVICE WAS REPLACED WITH COMPETITIVE FUSION DEVICES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Unspecified Musculoskeletal problem

  MAUDE report 17388970 ↗
• InjuryMay 22, 2023Migration; Migration

  A PATIENT REPORTED THAT A MOBI-C IMPLANT MIGRATED POST-OPERATIVELY AND IS CAUSING PAIN. THE DEVICE WAS PLACED AT LEVEL C5/6 AND WAS A SINGLE LEVEL CONSTRUCT. THE PATIENT EXPECTS TO HAVE A REVISION SURGERY TO REMOVE THE DEVICE.

  Patient problems: Neck Pain

  MAUDE report 16973386 ↗
• InjuryFeb 17, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C DEVICE AT C6/7 AFTER THE PATIENT DEVELOPED ANTERIOR HETEROTOPIC OSSIFICATION. THE PATIENT WAS CONVERTED TO A FUSION DEVICE.

  Patient problems: Extraskeletal ossification

  MAUDE report 16397819 ↗
• InjuryDec 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C DEVICES BECAUSE THEY WERE LOCKED IN A HYPERLORDOTIC POSITION IN FLEXION AND EXTENSION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphagia/ Odynophagia; Joint Laxity

  MAUDE report 16024006 ↗
• InjuryDec 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO MOBI-C DEVICES BECAUSE THEY WERE LOCKED IN A HYPERLORDOTIC POSITION IN FLEXION AND EXTENSION. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphagia/ Odynophagia; Joint Laxity

  MAUDE report 16024005 ↗
• InjuryNov 11, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT HAD RESIDUAL NECK PAIN AND SUBSIDENCE INTO THE SUPERIOR AND INFERIOR ENDPLATES APPROXIMATELY 6 WEEKS POST-OPERATIVELY. THIS OCCURRED AT THE C4/5 LEVEL OF A TWO-LEVEL TDR PROCEDURE AT C4/5 AND C5/6. THERE ARE NO PLANS FOR REVISION BUT THE PATIENT IS ON A MEDICATION FOR OSTEOPOROSIS.

  Patient problems: Neck Pain; Osteopenia/ Osteoporosis

  MAUDE report 15780844 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT THREE WEEKS POST-OP, THE SURGEON NOTED THE MOBI-C DEVICE STARTED TO SUBSIDE AT THE C6 VERTEBRA. THE SUBSIDENCE CONTINUED TO PROGRESS AND LED TO PATIENT PAIN, SO A REVISION WAS PERFORMED TO REMOVE THE MOBI-C AND CONVERT IT TO A FUSION.

  Patient problems: Neck Pain

  MAUDE report 15475297 ↗
• MalfunctionMar 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED AFTER IT WAS IMPLANTED: IT WAS PROPERLY IMPLANTED AND ADJUSTED TO GET INTO THE CORRECT POSITION. THEN THE SURGEON DECIDED TO REMOVE IT AND FOUND IT WAS IN TWO PIECES. ANOTHER MOBI-C IMPLANT WAS INSTALLED AFTER THIS DEVICE WAS REMOVED. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804021 ↗
• MalfunctionFeb 2, 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 13426694 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C DEVICE AT C5/6 DUE TO INSTABILITY, LISTHESIS, AND MYELOPATHY. THE LEVEL WAS CONVERTED TO A FUSION. THE PATIENT'S SYMPTOMS IMPROVED AFTER THE REVISION. THE SURGEON STATED THIS WAS PROBABLY NOT DEVICE RELATED.

  Patient problems: Intervertebral Disc Compression or Protrusion; Joint Laxity

  MAUDE report 12748721 ↗
• MalfunctionJun 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C DEVICE DISASSEMBLED ONCE IT WAS IMPLANTED. IT WAS REMOVED AND A NEW IMPLANT WAS USED TO COMPLETE THE CASE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093096 ↗
• MalfunctionMay 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUPERIOR ENDPLATE OF AN IMPLANT BECAME DISLODGED WHEN THE CARTRIDGE WAS REMOVED FOLLOWING RECOMMENDED SURGICAL TECHNIQUE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838893 ↗
• MalfunctionOct 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGERY, THE MOBI-C IMPLANT DID NOT FULLY DISENGAGE FROM THE IMPLANT HOLDER, AND IT DISASSEMBLED WHEN IT WAS PULLED OUT OF THE DISC SPACE WITH THE INSERTER. A NEW IMPLANT WAS USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WERE NO IMPACTS ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10744297 ↗
• MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT DISASSEMBLED IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND AN ALTERNATE IMPLANT OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADDITIONAL PATIENT IMPACTS OR SURGICAL DELAYS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9206009 ↗
• MalfunctionJul 18, 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 SURGERY, THE BOTTOM PLATE OF THE MOBI-C IMPLANT DISASSEMBLED FROM THE INSERTER WHEN THE SURGEON WENT TO RE-POSITION THE IMPLANT DURING INSERTION. THE IMPLANT WAS REMOVED AND A NEW IMPLANT WAS USED IN ITS PLACE. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801512 ↗
• MalfunctionJul 15, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  A MOBI-C IMPLANT WAS IMPLANTED IN A PATIENT AND LATER REMOVED IN THE SAME SURGERY. NO FURTHER SURGICAL OR PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8788704 ↗