Mobi-C® Plug & Fit US MB3575Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03662663000154), received between May 3, 2019 and May 4, 2026 — classified as 12 injuries, 19 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 18, 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.

• MalfunctionMay 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN TAMPING IN A MOBI-C IMPLANT INTRA-OPERATIVELY, IT DISASSEMBLED. THERE WAS ANOTHER IMPLANT AVAILABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074244 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED EXPERIENCING PAIN WITH TWO-LEVEL MOBI-C IMPLANTS AT C5/6 AND C6/7 APPROXIMATELY 6.5 YEARS POST-OPERATIVELY. THE PATIENT HAS USED MEDICATION AND PHYSICAL THERAPY AND STILL EXPERIENCES PAIN. FOLLOW-UP X-RAYS AND MRIS WERE INCONCLUSIVE, AND THE SURGEON SUGGESTED POSSIBLE IMPLANT REMOVAL, HOWEVER THE PATIENT DOES NOT WANT TO DO SO UNLESS ABSOLUTELY NECESSARY. THE PATIENT TESTED NEGATIVE FOR ALLERGY TO MOBI-C COMPONENTS. ANOTHER X-RAY WAS TAKEN AND SHOWS WHAT APPEARS TO BE CALCIFICATION OVER ONE OF THE IMPLANTS AND NO MOVEMENT OF IT. THE PATIENT CONTINUES TO CONSULT THEIR DOCTOR TO DETERMINE NEXT STEPS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 23417424 ↗
• InjuryOct 29, 2025Osseointegration Problem; Physical Resistance/Sticking; Osseointegration Problem; Physical Resistance/Sticking

  A PATIENT REPORTED EXPERIENCING PAIN WITH TWO-LEVEL MOBI-C IMPLANTS AT C5/6 AND C6/7 APPROXIMATELY 6.5 YEARS POST-OPERATIVELY. THE PATIENT HAS USED MEDICATION AND PHYSICAL THERAPY AND STILL EXPERIENCES PAIN. FOLLOW-UP X-RAYS AND MRIS WERE INCONCLUSIVE, AND THE SURGEON SUGGESTED POSSIBLE IMPLANT REMOVAL, HOWEVER THE PATIENT DOES NOT WANT TO DO SO UNLESS ABSOLUTELY NECESSARY. THE PATIENT TESTED NEGATIVE FOR ALLERGY TO MOBI-C COMPONENTS. ANOTHER X-RAY WAS TAKEN AND SHOWS WHAT APPEARS TO BE CALCIFICATION OVER ONE OF THE IMPLANTS AND NO MOVEMENT OF IT. THE PATIENT CONTINUES TO CONSULT THEIR DOCTOR TO DETERMINE NEXT STEPS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 23417422 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT FELT A FEELING OF ELECTRICITY RUN THROUGH HIS NECK AND HIS ARM FELL TO HIS SIDE. A REVISION SURGERY WAS PERFORMED IN WHICH A MOBI-C DEVICE WAS REMOVED AND REPLACED WITH A FUSION CAGE. THE SURGEON FOUND THAT THERE WAS A FRACTURED PIECE OF C7 BONE UNDER THE INFERIOR MOBI-C PLATE AND STATED "IT WAS NOT THE IMPLANT THAT FAILED, IT WAS THE PATIENT." HOWEVER, REVIEW OF THE X-RAYS BY THE MANUFACTURER IDENTIFIED THAT THE INFERIOR PLATE HAD MIGRATED ANTERIORLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s)

  MAUDE report 19735400 ↗
• InjuryApr 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A SURGEON CONDUCTED A REVISION SURGERY TO REMOVE A MOBI-C CERVICAL DISC DUE TO STRUCTURALLY DEFECTIVE NOTCHES IN THE POLY CORE THAT WORE SO THEY WERE 2X THE NORMAL SIZE RESULTING IN A 30% SPONDYLOLISTHESIS. THE IMPLANT WAS REPLACED WITH A COMPETITIVE DISC.

  Patient problems: Joint Laxity

  MAUDE report 19187931 ↗
• InjuryMar 22, 2024Migration; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CONVERT TO A FUSION FOLLOWING A MOBI-C IMPLANT THAT DEVELOPED SUBSIDENCE WITHIN THE DISC SPACE. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 18965123 ↗
• 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 TWO OF TWO FOR THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18699624 ↗
• MalfunctionOct 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ADJUSTING THE POSITION OF A MOBI-C IMPLANT IN THE DISC SPACE, THE DEVICE DISASSEMBLED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890344 ↗
• MalfunctionJul 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C DEVICE CAME APART DURING IMPACTION INTO THE DISC SPACE WITHOUT RELEASING WITH THE INSERTER. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C IMPLANT WITH NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389815 ↗
• InjuryNov 19, 2022Migration; Migration

  IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSOCIATED WHERE THE UPPER ENDPLATE RETROLISTHESED AND THE IMPLANT KICKED INTO HYPERLORDOSIS. THERE ARE PLANS TO PERFORM A REVISION SURGERY TO REMOVE THE MOBI-C AND CONVERT IT TO A FUSION. THE PATIENT CONTINUES TO HAVE NECK PAIN.

  Patient problems: Neck Pain

  MAUDE report 15831021 ↗
• MalfunctionNov 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT DETACHED FROM THE PEEK CARTRIDGE WHILE THE SURGEON WAS ROTATING THE IMPLANT INTRAOPERATIVELY. IT WAS REMOVED AND ANOTHER MOBI-C IMPLANT WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780530 ↗
• 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 ONE OF TWO FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 14677002 ↗
• MalfunctionMar 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED DURING IMPLANTATION IN THE DISC SPACE. IMAGING TAKEN AFTER SHOWED IT WAS INSTALLED SHOWED THE INFERIOR PLATE WAS ROTATED 90 DEGREES IN-SITU. WHEN THE DEVICE WAS REMOVED, THE SUPERIOR PLATE WAS STILL ATTACHED TO THE CARTRIDGE, HOWEVER THE POLY CORE AND INFERIOR PLATE WERE NOT ATTACHED BUT WERE SUCCESSFULLY RETRIEVED. ANOTHER IMPLANT WAS OPENED, LOADED ON THE SAME INSERTER, AND IMPLANTED WITHOUT COMPLICATION. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13932350 ↗
• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON INTRODUCTION OF THE MOBI-C IMPLANT INTO THE DISC SPACE C6-7, THE IMPLANT CAME APART WHEN IT HAD BEEN IMPACTED 2 TIMES. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690611 ↗
• MalfunctionJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN IMPLANT DISASSEMBLED DURING SURGERY. DURING INSTALLATION, THE SURGEON WANTED TO MAKE AN ADJUSTMENT TO THE IMPLANT POSITION SO HE PROCEEDED TO PULL THE IMPLANT OUT. THE INFERIOR PLATE AND POLY CORE REMAINED IN THE DISC SPACE WHILE THE SUPERIOR PLATE WAS REMOVED WITH THE CARTRIDGE AND INSERTER. THE INFERIOR PLATE AND POLY CORE WERE REMOVED FROM THE DISC SPACE AND ANOTHER MOBI-C WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948224 ↗
• MalfunctionFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C DEVICE DISASSEMBLED WHILE BEING REMOVED FROM THE DISC SPACE. IT WAS DECIDED THE DEVICE WAS TOO BIG FOR THE PATIENT, SO IT WAS BEING REMOVED SO A SMALLER DEVICE COULD BE INSTALLED. THERE WERE NO PATIENT IMPACTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11281391 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAS SUSPECTED INFECTION AFTER UNDERGOING A MOBI-C PROCEDURE. THE SURGEON NOTICED THE PATIENT'S NECK WAS RED AROUND THE SURGICAL INCISION. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 10906889 ↗
• MalfunctionOct 20, 2020Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT DURING A SURGERY, THE IMPLANT DISASSEMBLED WHEN THE SURGEON WENT TO REMOVE IT FROM THE INSERTER. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT WITHOUT ANY IMPACT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10705513 ↗
• MalfunctionJul 29, 2019Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, UPON INSERTING THE IMPLANT INTO THE DISC SPACE, THE TOP PLATE PIVOTED INTO FLEXION WHILE STILL ON THE INSERTER. AS THE SURGEON DID NOT FEEL COMFORTABLE LEAVING THE IMPLANT IN THIS POSITION, IT WAS REMOVED AND REPLACED WITH A NEW IMPLANT. NO PATIENT OR SURGICAL IMPACT WAS REPORTED.

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

  MAUDE report 8835402 ↗
• MalfunctionJul 18, 2019Disconnection; Fracture; Disconnection; Fracture

  IT WAS REPORTED THAT THE PEEK CARTRIDGE WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE IMPLANT NEVER TOUCHED THE PATIENT AND A SECOND IMPLANT WAS OPENED AND USED TO COMPLETE THE SURGERY. NO PATIENT IMPACTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801479 ↗
• MalfunctionJul 9, 2019Positioning Failure; Disconnection; Detachment of Device or Device Component; Positioning Failure; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE IMPLANT DISASSEMBLED WHILE HALFWAY IN THE DISC SPACE WHEN THE SURGEON WENT TO ADJUST THE POSITION. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT IMPACTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770998 ↗
• MalfunctionJun 21, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE IMPLANT DISASSEMBLED. THE IMPLANT WAS REMOVED AND REPLACED WITH AN ALTERNATE TO COMPLETE THE CASE WITHOUT REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721208 ↗
• InjuryJun 18, 2019Positioning Problem; Positioning Problem

  MOBI-C P&F US : POSITION INCORRECT POST-OP. IT WAS REPORTED THAT SALES REP. RECEIVED A TEXT MESSAGE FROM SURGEON WITH IMAGES OF MOBI-C IMPLANT THAT APPEARS TO DISPLACE WITH FLEXION. HE SAID PATIENT HAD NO CLINICAL ISSUES TO DATE. ASKED IF HE WOULD GET SOME CORPORATE FEEDBACK ON IMAGES. PATIENT IS ASYMPTOMATIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707163 ↗
• InjuryJun 18, 2019Positioning Problem; Positioning Problem

  MOBI-C P&F US : POSITION INCORRECT POST-OP. IT WAS REPORTED THAT SALES REP. RECEIVED A TEXT MESSAGE FROM SURGEON WITH IMAGES OF MOBI-C IMPLANT THAT APPEARS TO DISPLACE WITH FLEXION. HE SAID PATIENT HAD NO CLINICAL ISSUES TO DATE. ASKED IF HE WOULD GET SOME CORPORATE FEEDBACK ON IMAGES. PATIENT IS ASYMPTOMATIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707151 ↗
• MalfunctionJun 12, 2019Misassembled; Detachment of Device or Device Component; Misassembled; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANT DISASSEMBLED WHEN THE SCRUB TECH ATTEMPTED TO DETACH AND REATTACH TO THE INSERTER. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE CASE WITHOUT REPORTED PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690656 ↗