Mobi-C® Plug & Fit US MB3595Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03662663000185), received between May 20, 2019 and Nov 25, 2025 — classified as 8 injuries, 3 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Migration; Migration

  IT WAS REPORTED THAT A MOBI-C REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR MIGRATION, AND INVOLVED EXPLANTATION OF C5/C6 AND FUSION WITH TRELLOSS CSA.

  Patient problems: Insufficient Information

  MAUDE report 23650763 ↗
• MalfunctionOct 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED DURING IMPLANTATION. THE SURGERY WAS COMPLETED USING A NEW IMPLANT, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381380 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT VIA VOLUNTARY MEDWATCH MW5162232 REPORTED HAVING MULTIPLE CLINICAL SYMPTOMS AFTER HAVING A MOBI-C IMPLANT INSTALLED. SYMPTOMS INCLUDE: UNABLE TO LIFT RIGHT ARM IMMEDIATELY POST-OP, WEAKNESS WHEN LIFTING ARM AT TIME OF DISCHARGE FROM HOSPITAL, SEVERE INFECTION DAYS AFTER SURGERY WHICH WAS TREATED WITH ANTIBIOTICS, HOSPITALIZATION FOR AN ACUTE PSYCHIATRIC EVENT ABOUT ONE-TWO MONTHS POST-OP, LOST FULL USE OF RIGHT AND LEFT ARM, THEN A REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE YEAR POST-OP. NO DETAILS WERE PROVIDED FOR THE REASON FOR OR ACTIONS TAKEN DURING THE REVISION SURGERY. APPROXIMATELY TWO YEARS POST-REVISION, THE PATIENT WAS DIAGNOSED WITH ALS BUT HER CONDITION HAS REMAINED STABLE AND THERE HAS NOT BEEN MUCH FURTHER WEAKNESS. THE PATIENT RECENTLY FELL WHICH PROMPTED A LUMBAR PUNCTURE. THE PATIENT IS EXPLORING HAVING A METAL SENSITIVITY OR AN ANTI-INFLAMMATORY RESPONSE TO SEE IF THAT CAUSED THE CONDITION. IMAGING SHOWS FATTY MUSCLE INFILTRATION: "POSSIBLY REPRESENTING POST INFECTIOUS OR INFLAMMATORY PROCESS" EDEMA OR PARASPINAL MUSCLES AND LEPTOMENINGEAL ENHANCEMENT. NO DISCRETE MASS OR LESION. RADIOLOGY HAS MIXED IMPRESSIONS THROUGH THE YEARS, BUT NOTHING DEFEC

  Patient problems: Failure of Implant; Fall; Unspecified Infection

  MAUDE report 21104284 ↗
• InjuryNov 14, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HETEROTOPIC OSSIFICATION. A REVISION SURGERY IS SCHEDULED TO REMOVE THE DEVICE.

  Patient problems: Extraskeletal ossification

  MAUDE report 15789402 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT LOST MOTOR SIGNALS DURING SURGERY AFTER THE SURGEON REMOVED A LARGE HERNIATION FROM THE SPINAL CORD. THE SURGEON INSTALLED A MOBI-C IMPLANT AFTER THERE WERE NO ISSUES WITH THE CORD OR EXITING NERVE ROOTS FOUND. THE PATIENT WAS PARALYZED AFTER WAKING UP IN THE RECOVERY ROOM. A REVISION SURGERY WAS LATER PERFORMED TO REMOVE THE TWO MOBI-C DEVICES AND INSTALL A FUSION CONSTRUCT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 11084381 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT LOST MOTOR SIGNALS DURING SURGERY AFTER THE SURGEON REMOVED A LARGE HERNIATION FROM THE SPINAL CORD. THE SURGEON INSTALLED A MOBI-C IMPLANT AFTER THERE WERE NO ISSUES WITH THE CORD OR EXITING NERVE ROOTS FOUND. THE PATIENT WAS PARALYZED AFTER WAKING UP IN THE RECOVERY ROOM. A REVISION SURGERY WAS LATER PERFORMED TO REMOVE THE TWO MOBI-C DEVICES AND INSTALL A FUSION CONSTRUCT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 11084337 ↗
• InjuryJun 19, 2019Disconnection; Disconnection

  MOBI-C P&F US: DISASSEMBLY. IT WAS A CERVICAL DISC REPLACEMENT. ISSUE OCCURED WHILE LOADING THE IMPLANT ON THE INSERTER. AS DESCRIBED BY REPORTER : THE HOSPITAL SURGICAL TECHNOLOGIST THREADED THE IMPLANT OFF THE INSERTER . ANOTHER IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. NO IMPACT ON PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712561 ↗
• MalfunctionJun 12, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INFERIOR ENDPLATES OF TWO MOBI-C IMPLANTS DISLODGED FROM THE IMPLANT DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A THIRD MOBI-C IMPLANT. THERE WAS NO DELAY IN SURGERY AND NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690655 ↗
• MalfunctionJun 12, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INFERIOR ENDPLATES OF TWO MOBI-C IMPLANTS DISLODGED FROM THE IMPLANT DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A THIRD MOBI-C IMPLANT. THERE WAS NO PATIENT IMPACT REPORTED. THIS IS REPORT ONE OF TWO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690651 ↗
• InjuryJun 12, 2019Disconnection; Malposition of Device; Disconnection; Malposition of Device

  MOBI-C P&F US: DISASSEMBLED DURING ADJUSTMENT. IT WAS REPORTED BY A SALES REPRESENTATIVE DURING A MOBI-C SURGERY THAT SURGEON PLACED IMPLANT AND WHEN SHE WENT TO ADJUST AND TAP IN IT FELL APART. NO INJURY TO PATIENT REPORTED. A DELAY OF 10 MIN OCCURED. SURGERY WAS COMPLETED WITH A DEVICE OF SAME SIZE WITHOUT FURTHER COMPLICATION. ADDITIONAL INFORMATIONS WERE RECEIVED ON MAY 30TH : PATIENT IS HEALTHY. THE LEVEL IMPLANTED WAS C3/C4. THE DEPTH STOP ADJUSTMENT SET INITIALLY AT ZERO. THE SURGICAL TECHNIQUE WAS FOLLOWED AT THE MOBI-C LOADING ON INSERTER. THE SURGEON DID NOT ENCOUNTER RESISTANCE WHILE INSERTING PROSTHESIS. THE SURGEON DID NOT USE THE MOBI-C NO TOUCH LEVEL AND THE MOBI-C DISTRACTION FORCEPS. SURGERY COMPLETED WITH A NEW IMPLANT OF THE SAME SIZE WITHOUT FURTHER COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690372 ↗
• InjuryMay 20, 2019Malposition of Device; Device Dislodged or Dislocated; Positioning Problem; Malposition of Device; Device Dislodged or Dislocated; Positioning Problem

  MOBI-C P&F US : DISASSEMBLED AS REPORTED BY SALES REP: DURING A MOBI-C SURGERY, PATIENT EXPERIENCING RADIATING PAIN OFF AND ON, 2-3 YEARS POST OP. COMPUTED TOMOGRAPHY DONE AND SHOWS HETEROTOPIC OSSIFICATION. AND DURING THE TWO LEVEL CERVICAL SURGERY THAT OCCURED IN (B)(6) 2019 , IMPLANT WAS PUT IN, FELL APART WHEN BACKED OUT AND REMOVED. THIS REPORT IS ABOUT THE DISASSEMBLY CASE. ADDITIONAL REQUEST WERE SENT ABOUT THE HETEROTOPIC OSSIFICATION THAT WILL BE TREATED IN SEPARATE COMPLAINT. THE CURRENT STATE OF HEALTH OF PATIENT IS GOOD, THE LEVEL IMPLANTED WERE C5/6-C6/7. THE DEPTH STOP ADJUSTMENT WAS SET INITIALLY AT ZERO. THE SURGICAL TECHNIQUE WAS FOLLOWED AT THE MOBI-C LOADING ON INSERTER (TAKE CARE TO STOP THREADING AS SOON AS FULL CONTACT IS ACHIEVED IN ORDER TO AVOID PREMATURE OPENING OF THE PEEK CARTRIDGE AND RELEASING THE IMPLANT). DISC SPACE WAS UNDER DISTRACTION. THE SURGEON DIDN'T ENCOUNTER RESISTANCE WHILE INSERTING PROSTHESIS. IT WAS NOT SURE IF PROSTHESIS COULD HAVE BEEN INSERTED WITH AN ANGLE OR IF A ROTATIONAL MOVE WAS DONE WHILE INSERTING PROSTHESIS. NO DIFFERENCE IN SURGICAL STEPS WAS NOTICED BETWEEN THE FIRST AND THE SECOND IMPLANT. NO X-RAYS ARE AVAILABLE. THE SURG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8623002 ↗