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Mobi-C® Plug & Fit US MB3555Recalls & reported problems

LDR Spine Usa, Inc. · Total Cervical Disc Replacement System: Mobi-C Cervical Disc Prosthesis · Class 3 · Implant

All models of Mobi-C Plug & Fit US (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
22
Deaths reported
0
Injuries reported
13
Recalls naming it
0

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03662663000062), received between May 21, 2019 and Jan 14, 2026 — classified as 13 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component8
  • Migration5
  • Device Dislodged or Dislocated3
  • Adverse Event Without Identified Device or Use Problem2
  • Malposition of Device2
  • Patient Device Interaction Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Biocompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • Pain6
  • Neck Pain4
  • No Known Impact Or Consequence To Patient3
  • Numbness2
  • Unspecified Musculoskeletal problem2
  • Cramp(s) /Muscle Spasm(s)1
  • Extraskeletal ossification1

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 14, 2026Device Dislodged or Dislocated

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN WHICH TWO MOBI-C IMPLANTS WERE REMOVED AND CONVERTED TO FUSION DUE TO LOOSENING ENDPLATES AND ONE ENDPLATE THAT WAS ANGLED ANTERIORLY. THERE WERE NO REPORTED PATIENT IMPACTS BEYOND THE REVISION SURGERY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24068733 ↗
  • InjuryJan 13, 2026Malposition of Device; Device Dislodged or Dislocated

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN WHICH TWO MOBI-C IMPLANTS WERE REMOVED AND CONVERTED TO FUSION DUE TO LOOSENING ENDPLATES AND ONE ENDPLATE THAT WAS ANGLED ANTERIORLY. THERE WERE NO REPORTED PATIENT IMPACTS BEYOND THE REVISION SURGERY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24062137 ↗
  • InjuryNov 25, 2025Migration; Migration

    A PATIENT REPORTED VIA VOLUNTARY MEDWATCH THAT THEY RECEIVED A MOBI-C IMPLANT AND BEGAN EXPERIENCING A SHARP, TINGLING SENSATION IN THEIR LEFT ARM AND ADDITIONALLY PAIN POST-OPERATIVELY. X-RAYS REVEALED THAT THE DISC NEEDS TO BE REPLACED DUE TO MIGRATION. THE PATIENT IS CURRENTLY OBTAINING A SECOND OPINION AND NO SURGERY IS SCHEDULED YET.

    Patient problems: Neuropathy; Pain; Skin Burning Sensation

    MAUDE report 23650425 ↗
  • MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED AFTER IMPLANTATION WHEN THE SURGEON ATTEMPTED TO REMOVE TO ADJUST POSITIONING. THE IMPLANT WAS RETRIEVED AND ANOTHER MOBI-C IMPLANT WAS USED. THE IMPLANT WAS DISCARDED BY THE FACILITY. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23373339 ↗
  • InjuryAug 12, 2025Migration; Migration

    IT WAS REPORTED THAT TWO MOBI-C CERVICAL IMPLANTS MIGRATED POST-OPERATIVELY AS A RESULT OF A CAR ACCIDENT, CAUSING CERVICAL PAIN. A REVISION SURGERY WAS PERFORMED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Patient problems: Neck Pain

    MAUDE report 22783657 ↗
  • MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED IN THE DISC SPACE INTRA-OPERATIVELY. THE SURGEON ASKED THE FELLOW TO ADJUST THE DEPTH OF IMPLANT AND RETRACT 1MM. WHEN THE FELLOW DID SO, THE BOTTOM PLATE, AND ONLY BOTTOM PLATE, DISENGAGED FROM PEAK CARTRIDGE. A NEW IMPLANT WAS USED TO PERFORM THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A FIVE-MINUTE DELAY TO OPEN AND LOAD A NEW IMPLANT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22461693 ↗
  • MalfunctionDec 11, 2024Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

    IT WAS REPORTED THAT DURING A SURGERY, A MOBI-C IMPLANT DISASSEMBLED IN THE DISC SPACE AND WAS DIFFICULT TO REMOVE FROM THE INSERTER. THE IMPLANT WAS REPLACED AND THE SURGERY WAS COMPLETED WITH ONLY A 5-7 MINUTE DELAY AND NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20904961 ↗
  • InjuryDec 20, 2023Fracture; Malposition of Device; Fracture; Malposition of Device

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A MOBI-C CONSTRUCT THAT WAS CAUSING PAIN AND NUMBNESS IN THE PATIENT. DURING THE REVISION SURGERY IT WAS DISCOVERED THAT THE LEFT ANTERIOR CORNER OF THE MOBILE CORE HAD FRACTURED, ALLOWING THE CORE TO SHIFT ALIGNMENT AND COLLAPSING THE POSTERIOR PORTION OF THE C3-C4 CONSTRUCT. THE MOBI-C WAS REMOVED AND REPLACED WITH AN ACDF.

    Patient problems: Numbness; Pain

    MAUDE report 18364910 ↗
  • 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 TWO OF TWO FOR THIS EVENT.

    Patient problems: Pain

    MAUDE report 17715416 ↗
  • InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE UNSPECIFIED SYMPTOMS 8 DAYS POST-OPERATIVELY AFTER A MOBI-C DEVICE WAS IMPLANTED. THE PATIENT SCHEDULED A REVISION SURGERY TO REMOVE THE MOBI-C DEVICE AND CONVERT IT TO AN ACDF WITH A DIFFERENT SURGEON.

    Patient problems: Unspecified Musculoskeletal problem

    MAUDE report 17552939 ↗
  • InjuryFeb 17, 2023Migration; Migration

    IT WAS REPORTED THAT A MOBI-C DEVICE SUBSIDED AT C4/5 AFTER THE PATIENT WENT ON AN AMUSEMENT PARK RIDE THREE MONTHS POST-OPERATIVELY. THE PATIENT WAS INITIALLY TREATED NON-OPERATIVELY FOR NEW LEFT SHOULDER AND ARM PAIN. HOWEVER, A REVISION SURGERY WAS LATER PERFORMED TO REMOVE THE MOBI-C DEVICES AT C3/4 AND C4/5 AND REPLACE THEM WITH COMPETITIVE PRODUCT AFTER THE DEVICE AT C3/4 MIGRATED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Patient problems: Pain

    MAUDE report 16397925 ↗
  • MalfunctionFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A MOBI-C TOP ENDPLATE SEPARATED FROM THE DEVICE UPON INSERTION. THE SURGEON REQUESTED A NEW DEVICE. SURGERY WAS DELAYED FOR 10 MINUTES WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16362597 ↗
  • InjuryNov 14, 2022Migration; Migration

    IT WAS REPORTED THAT A MOBI-C DEVICE SUBSIDED AFTER THE PATIENT WENT ON AN AMUSEMENT PARK RIDE THREE MONTHS POST-OPERATIVELY. THE PATIENT IS CURRENTLY BEING TREATED NON-OPERATIVELY FOR NEW LEFT SHOULDER AND ARM PAIN. HOWEVER, A FUTURE REVISION TO REMOVE THE MOBI-C AND CONVERT IT TO AN ACDF HAS NOT BEEN RULED OUT.

    Patient problems: Pain

    MAUDE report 15789281 ↗
  • InjuryMay 9, 2022Expiration Date Error; Patient Device Interaction Problem; Migration; Expiration Date Error; Patient Device Interaction Problem; Migration

    IT WAS REPORTED THAT A MOBI-C PATIENT HAS LOSS OF MOTION DUE TO BONE SPURS ABOVE AND BELOW C5/6 (WHERE THE MOBI-C WAS IMPLANTED) AND IS HAVING AN ALLERGIC REACTION TO NICKEL. PATIENT IS EXPERIENCING PAIN, MUSCLE SPASMS, SHOCKS, SWELLING, AND LOSING FEELING IN ARMS AND LEGS. THE DEVICE REMAINS IMPLANTED.

    Patient problems: Cramp(s) /Muscle Spasm(s); Extraskeletal ossification; Failure of Implant; Hearing Impairment; Loss of Range of Motion; Loss of Vision; Memory Loss/Impairment; Neck Pain; Neurogenic Shock; Numbness; Swelling/ Edema; Unspecified Infection; Unspecified Musculoskeletal problem

    MAUDE report 14337235 ↗
  • MalfunctionMar 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SUPERIOR PLATE OF A MOBI-C IMPLANT DISASSEMBLED WHILE BEING IMPACTED INTO THE DISC SPACE. IT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C IMPLANT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13736979 ↗
  • MalfunctionFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED AFTER BEING INSTALLED: THE SURGEON HAD IMPLANTED THE DEVICE AND THE INFERIOR PLATE LOOKED DISLODGED AND TILTED ON THE ANTERIOR PORTION NEXT TO THE ENDPLATE. IT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C IMPLANT TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13497875 ↗
  • InjuryJan 14, 2022Biocompatibility; Biocompatibility

    IT WAS REPORTED THAT THE PATIENT DISCOVERED A PREVIOUSLY-UNKNOWN ALLERGY AFTER A MOBI-C DEVICE WAS IMPLANTED. THE PATIENT IS UNDERGOING ALLERGY TESTING, BUT NO TREATMENT PLANS HAVE BEEN MADE YET.

    Patient problems: Inflammation; Neck Pain

    MAUDE report 13259191 ↗
  • MalfunctionDec 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE SUPERIOR PLATE DETACHED FROM THE INSERTER DURING INSERTION IN THE DISC SPACE INTRA-OPERATIVELY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13018168 ↗
  • InjuryDec 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THE PATIENT HAD PERSISTENT NECK PAIN AND THE SURGEON ELECTED TO REMOVE THE MOBI-C IMPLANT AT C6/7 AND CONVERT IT TO AN ACDF.

    Patient problems: Neck Pain

    MAUDE report 13003367 ↗
  • MalfunctionJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE SURGEON WAS PLACING THE IMPLANT, HE HIT THE KNOB WITH THE MALLET WHEN THE PEAK CARTRIDGE RELEASED FROM THE IMPLANT AND THE IMPLANT DISASSEMBLED IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND AN ALTERNATE OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9566571 ↗
  • InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT A MOBI-C IMPLANT WAS REMOVED FROM A PATIENT SEVERAL YEARS AFTER INITIALLY IMPLANTING. THE PATIENT REPORTED CONTINUED PAIN AFTER THE ORIGINAL SURGERY WITH VERY LITTLE IMPROVEMENT. THE SURGEON NOTED THAT UPON REMOVAL, NOTHING APPEARED TO BE WRONG WITH THE DEVICE.

    Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Pain

    MAUDE report 8706936 ↗
  • MalfunctionMay 21, 2019Partial Blockage; Device Dislodged or Dislocated; Device Handling Problem; Partial Blockage; Device Dislodged or Dislocated; Device Handling Problem

    IT WAS REPORTED THAT THE INFERIOR ENDPLATE OF THE IMPLANT WAS NOTED TO BE LOCKED AT AN ODD ANGLE IN THE DISC SPACE DURING SURGERY. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8626891 ↗

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Sources and updates

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