M6-C 6MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00812388030018), received between Feb 23, 2023 and Oct 6, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Collapse” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DR. (B)(6) EXPERIENCED AN M6-C DEVICE FAILURE WHICH WAS SUBSEQUENTLY EXPLANTED FROM ONE OF HIS PATIENTS. DR. (B)(6) REQUESTED THAT THE EXPLANTED DEVICE BE RETURNED FOR INTERNAL INSPECTION. ACCORDING TO INFORMATION OBTAINED FROM THE PATIENT'S HUSBAND, THE PATIENT PREVIOUSLY HAD A PRODISC IMPLANTED (IMPLANT DATE UNKNOWN) AND LATER UNDERWENT A REVISION PROCEDURE IN 2020 PERFORMED BY DR. (B)(6). THE PATIENT WAS INITIALLY INFORMED THAT A CAGE WOULD BE IMPLANTED, HOWEVER INTRAOPERATIVELY DR. (B)(6) ELECTED TO IMPLANT A TWO-LEVEL M6-C. THE PATIENT LATER PRESENTED TO DR. (B)(6), WHO EXPLANTED BOTH OF THE M6-C DEVICES ON (B)(6) 2025. THE PATIENT'S HUSBAND REPORTED THAT THE PATIENT HAS EXPERIENCED CHRONIC PAIN FOR SEVERAL YEARS AND THAT BONE RESORPTION HAD BEGUN. NO IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23227760 ↗
• InjuryOct 6, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DR. (B)(6) EXPERIENCED AN M6-C DEVICE FAILURE WHICH WAS SUBSEQUENTLY EXPLANTED FROM ONE OF HIS PATIENTS. DR. (B)(6) REQUESTED THAT THE EXPLANTED DEVICE BE RETURNED FOR INTERNAL INSPECTION. ACCORDING TO INFORMATION OBTAINED FROM THE PATIENT'S HUSBAND, THE PATIENT PREVIOUSLY HAD A PRODISC IMPLANTED (IMPLANT DATE UNKNOWN) AND LATER UNDERWENT A REVISION PROCEDURE IN 2020 PERFORMED BY DR. (B)(6). THE PATIENT WAS INITIALLY INFORMED THAT A CAGE WOULD BE IMPLANTED; HOWEVER INTRAOPERATIVELY DR. (B)(6) ELECTED TO IMPLANT A TWO-LEVEL M6-C. THE PATIENT LATER PRESENTED TO DR. (B)(6), WHO EXPLANTED BOTH OF THE M6-C DEVICES ON (B)(6) 2025. THE PATEINT'S HUSBAND REPORTED THAT THE PATIENT HAS EXPERIENCED CHRONIC PAIN FOR SEVERAL YEARS AND THAT BONE RESORPTION HAD BEGUN. NO IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23223401 ↗
• InjuryApr 11, 2025Collapse; Collapse

  IT WAS REPORTED THAT THERE WAS DISC LUCENCY AND COLLAPSE OF M6-C DISC AFTER PATIENT HAD A FALL AND HAD NECK PAIN, INCIDENTAL FINDING.

  Patient problems: Neck Pain

  MAUDE report 21827540 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS -M6C REVISION CASE-- BLUMENTHAL ET AL (ESJ 2024). DISCUSSES THE OUTCOMES AND MANAGEMENT STRATEGIES FOR PATIENTS WHO UNDERWENT REVISION OR REMOVAL OF CERVICAL TOTAL DISC REPLACEMENTS (TDR). THE MOST COMMON REASON FOR REMOVAL/REVISION ENCOUNTERED IN THIS COHORT WAS SEVERE OSTEOLYSIS, 7 WERE M6-C.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 20306495 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A REMOVAL OF C3/4 AND C4/5 M6-C IMPLANTED IN 2021 - SOUTH AFRICAN PATIENT - PROBABLY FIRST IMPLANTED THERE.

  Patient problems: Implant Pain

  MAUDE report 20304354 ↗
• InjuryJan 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT LEVEL C5/6 IN (B)(6) 2019. PATIENT BEGAN EXPERIENCING PAIN 4 YEARS POST IMPLANTING. THE TOTAL DISC REPLACEMENT WAS EXPLANTED AND REPLACED WITH ACDF IN (B)(6) 2023.

  Patient problems: Neck Pain

  MAUDE report 18567962 ↗
• InjuryDec 2, 2023Collapse; Collapse

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C6/7 LEVEL IN 2016. PATIENT EXPERIENCED PAIN, NUMBNESS, DIZZINESS AND TENSION. THE DEVICE WAS EXPLANTED IN (B)(6) 2023 DUE TO CLINICAL SYMPTOMS.THE DEVICE WAS NOT INTACT AT THE TIME OF REMOVAL.

  Patient problems: Dizziness; Numbness; Pain

  MAUDE report 18253313 ↗
• MalfunctionNov 1, 2023Collapse; Collapse

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C ARTIFICIAL CERVICAL DISC IMPLANTED AT C5-6 IN 2018. A REVISION SURGERY TO REMOVE M6-C AND CONVERT TO ACDF IN (B)(6) 2023 DUE TO OSTEOLYSIS AND COLLAPSE OF THE M6-C.

  Patient problems: Failure of Implant

  MAUDE report 18052595 ↗
• MalfunctionOct 11, 2023Material Separation; Material Separation

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED IN 2013 AT C4/5. IT WAS NOT REPORTED IF PATIENT EXPERIENCED ANY SYMPTOMS HOWEVER IT WAS REPORTED THAT THE M6-C HAD COLLAPSED AND OSTEOLYSIS WAS PRESENT. RADIOGRAPHIC IMAGES SHOW THAT THE PATIENT HAD A 2 LEVEL ACDF AT LEVELS C5/6 AND C6/7. IT IS UNKNOWN WHETHER THAT FUSION WAS PERFORMED BEFORE OR AFTER THE IMPLANTATION OF THE M6-C DISC AT C4/5. THE M6-C DEVICE WAS REMOVED DUE TO COLLAPSED DISC.

  Patient problems: Insufficient Information

  MAUDE report 17917067 ↗
• InjurySep 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION PROVIDED STATES THAT AN M6-C WAS IMPLANTED AT C4/5 ON (B)(6) 2021. THE PATIENT REPORTED INCREASED NECK PAIN. THE M6-C DEVICE WAS REMOVED ON (B)(6) 2023 DUE TO SUSPECTED LOOSENING OF THE DEVICE.

  Patient problems: Neck Pain

  MAUDE report 17821427 ↗
• InjuryJul 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED IN 2019 AT C5/6 AND C7/T1. PATIENT HAD PREVIOUS FUSION AT C6/7 IN 2016. THE PATIENT EXPERIENCED NON-SPECIFIC NECK PAIN. THE MRI SHOWED SIGNS OF INFECTION. THE M6-C WAS REMOVED DUE TO SUSPECTED INFECTION.

  Patient problems: Neck Pain

  MAUDE report 17427944 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C5/6 ON (B)(6) 2022. PT EXPERIENTS CERVICAL NECK PAIN AND DISCOMFORT AT IMPLANT LEVEL. THE M6-C WAS REMOVED ON (B)(6) 2023.

  Patient problems: Implant Pain

  MAUDE report 17114116 ↗
• InjuryMay 2, 2023Collapse; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Collapse; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT A REVISION SURGERY WAS PERFORMED TO REMOVE TWO COLLAPSED M6-C DISCS THAT WERE IMPLANTED 12/13 YEARS AGO. NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Insufficient Information; Neck Pain; Neck Stiffness; Osteolysis

  MAUDE report 16850881 ↗
• InjuryFeb 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION PROVIDED STATES THE PATIENT EXPERIENCED PAIN AND LYSIS ZONE COULD BE SEEN IN THE BONE 13 YEARS POST IMPLANT OF AN M6-C PROSTHESIS. THE PATIENT HAD BEEN DIAGNOSED WITH MULTIPLE SCLEROSIS AT THE TIME OF INITIAL IMPLANT IN 2010. THE M6-C WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16432435 ↗