M6-C 6MLRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00812388030025), received between Jun 24, 2022 and Apr 1, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Insufficient Device Problem Information

  AS PER REPORTER AN M6 DEVICE WAS EXPLANTED DUE TO OSTEOLYSIS OF THE ADJACENT BONE WITH EVIDENCE OF PARTICLE ABRASION.

  Patient problems: Osteolysis

  MAUDE report 24758093 ↗
• InjuryMar 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THERE WAS A REVISION OF A CDM-635L DUE TO OSTEOLYSIS AND ACCORDING TO HISTOLOGICAL FINDINGS A POLYETHYLENE CAUSED GRANULOMA.

  Patient problems: Granuloma; Osteolysis

  MAUDE report 24643571 ↗
• InjurySep 12, 2024Collapse; Insufficient Device Problem Information; Collapse; Insufficient Device Problem Information

  IT WAS REPORTED THAT DR. (B)(6) IN (B)(6) HAS REACHED OUT REGARDING A M6 PATIENT FROM 4 YEARS AGO WITH SIGNIFICANT OSTEOLYSIS.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 20207018 ↗
• InjuryApr 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PREVIOUS INITIAL AND FOLLOW UP REPORTS WERE SUBMITTED USING AN INCORRECT MFR REPORT NUMBER 3004897282-2024-0003. THIS REPORT INCLUDES ALL OF THE INFORMATION KNOWN AT THAT TIME AND ALSO THE SUPPLEMENTAL INFORMATION RECEIVED. PLEASE USE THIS REPORT TO REPLACE PREVIOUS REPORTS UNDER THE 3004897282-2024-00003 REPORTS. INFORMATION PROVIDED STATED THAT AN M6-C ARTIFICIAL CERVICAL DISC WAS IMPLANTED AT C5/6 IN 2014. THE M6-C WAS EXPLANTED (B)(6) 2024 DUE TO PATIENT EXPERIENCING DYSPHAGIA WITH OSTEOLYSIS SEEN ON CT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 19012180 ↗
• InjuryFeb 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION PROVIDED STATES THAT AN M6-C ARTIFICIAL CERVICAL DISC WAS IMPLANTED AT C5/6 IN 2014. THE M6-C WAS EXPLANTED ON (B)(6) 2024 DUE TO PATIENT EXPERIENCING DYSPHAGIA WITH OSTEOLYSIS SEEN ON CT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18771651 ↗
• InjuryOct 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION PROVIDED STATES THAT PATIENT HAD AN M6-C ARTIFICIAL CERVICAL DISC IMPLANTED AT C5/6 IN (B)(6) 2021. PATIENT WAS EXPERIENCING NECK DISCOMFORT WITH RIGHT ARM PAIN SUSPECTED DUE TO LOOSENING OF THE M6-C. DEVICE WAS EXPLANTED AND REPLACED WITH ACDF.

  Patient problems: Pain

  MAUDE report 17985904 ↗
• InjuryJul 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C5/6 IN (B)(6) 2018. RADIOGRAPHIC IMAGES REVEALED BONE LOSS IN THE C5 AND C6 VERTEBRAL BODIES. THE PATIENT UNDERWENT REMOVAL OF THE M6-C DISC IN (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17389464 ↗
• InjuryJul 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES PATIENT INVOLVED IN ACCIDENT IN (B)(6) 2015. IN (B)(6) 2016 PATIENT EXP NECK AND SHOULDER PAIN. PATIENT HAD M6-C IMPLANTED AT C5/6 IN (B)(6) 2016. PATIENT EXPERIENCED NECK/BACK PAIN, HEADACHES NUMBNESS/TINGLING. PATIENT UNDERWENT REMOVAL OF THE M6-C DISC AND CERVICAL SPINE FUSION IN (B)(6) 2022.

  Patient problems: Neck Pain; Numbness

  MAUDE report 17373538 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT WAS IMPLANTED WITH M6-C ARTIFICIAL CERVICAL DISC IN 2021 AT C6/7 WITH ACDF AT C5/6. PATIENT EXPERIENCED SWELLING AND A PUSS COLLECTION IN HER NECK IMMEDIATELY POST-IMPLANT. INFECTION AND PUSS WERE SEEN TO MOVE AROUND THE M6C IN THE LAST MONTH RESULTING IN THE REMOVAL OF IMPLANT AND REPLACED WITH ILIAC CREST. THE PATIENT IS CURRENTLY BEING TREATED WITH ANTIBIOTICS.

  Patient problems: Inflammation

  MAUDE report 17156628 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD AN M6-C ARTIFICIAL CERVICAL DISC IMPLANTED AT C5/6 IN (B)(6) 2022. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE DEVICE DUE TO PATIENT INCURRING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17015203 ↗
• InjuryMay 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION PROVIDED STATES THAT PT HAD TWO (2) M6-C ARTIFICIAL CERVICAL DISCS IMPLANTED IN 2019. THE PATIENT PRESENTED WITH A MASS IN THE THROAT. INFLAMMATION WAS SUSPECTED AND BOTH OF THE DEVICES WERE REMOVED AND REPLACED WITH ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION).

  Patient problems: Inflammation

  MAUDE report 16902190 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C4/5 AND 2 LEVEL FUSION AT C5/6 - C6/7 AT UNKNOWN TIME. M6-C WAS EXPLANTED DUE TO FACET ARTHROPTHY AND A FUSION WAS PERFORMED.

  Patient problems: Arthritis

  MAUDE report 16436238 ↗
• InjuryJun 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AN M6-C PATIENT REPORTEDLY HAD USSUES SWALLOWING AND HAD MRI. THERE WAS SUSPECTED INFECTION REPORTED AND THE DEVICE WAS EXPLANTED. THE DEVICE WAS INTACT AT THE TIME OF REMOVAL.

  Patient problems: Unspecified Infection

  MAUDE report 14807194 ↗