M6-C 6LRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00812388030032), received between Jul 20, 2022 and Aug 5, 2025 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Collapse; Collapse

  STUDY SUBJECT (B)(6) WAS TREATED IN THE M6-C 1-LEVEL IDE ON (B)(6) 2015 AND CONTINUED IN THE POST-APPROVAL STUDY (PAS) TO THE FINAL 10 YEAR FOLLOW UP VISIT ON (B)(6) 2025. DURING THE 10 YEAR FOLLOW-UP VISIT, THE PATIENT REPORTED EXPERIENCING INCREASED PAIN (REPORTED PAIN AS 7/10) AND TENSION WITH RADICULOPATHY DOWN HIS RIGHT SHOULDER. NEUROLOGICAL EXAM IS NORMAL. IMAGING SHOWED COMPLETE COLLAPSE OF THE DISC IMPLANT WITH THE CORE DISLOCATED (DISLOCATION IS ANTERIORLY BUT LOCATION OF CORE IS TO BE CONFIRMED BY CT SCAN TO BE OBTAINED IN THE NEXT COUPLE OF WEEKS. REMOVAL OF THE DEVICE IS TO BE SCHEDULED AT THE END OF (B)(6) 2025. COLLAPSE C5-6.

  Patient problems: Neck Pain

  MAUDE report 22716477 ↗
• InjuryMar 27, 2025Adverse 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 THERE WAS A REVISION OF C5/6 M6-C. PLANNED TO REPLACE IT WITH AN ACDF OR CORPECTOMY USING AUTOGRAFT AND PLATE FOR FIXATION.

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

  MAUDE report 21713483 ↗
• InjuryMar 27, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT A SURGEON HAD TO REVISE AN M6 PROSTHESIS. IT IS ALLEGED THE DEVICE HAS TO BE DESTROYED TO GET IT OUT OF THE PATIENT BUT IT ALREADY APPEARED BEING NOT INTACT IN-SITU (SHIFTED END PLATES/ DAMAGED CORE SKIN).

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

  MAUDE report 21713007 ↗
• InjuryDec 18, 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/REVISION CASE BECAUSE THE IMPLANT FAILED. THE ORIGINAL CASE WAS ON (B)(6) 2022. A PLATE AND CAGE WERE USED ON THE REVISION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20969256 ↗
• InjuryNov 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE STUDY SUBJECT (B)(6) WAS TREATED IN THE M6-C 2 LEVEL IDE ON (B)(6)2024. THE PATIENT WAS SEEN ON (B)(6) 2024 FOR THE 6-MONTH POST-OP STUDY VISIT AND REPORTED ACHY PAIN IN THE NECK ALONG WITH NUMBNESS AND TINGLING IN FINGERS 2,3, & 4. IMAGING SHOWED INCREASED ANGULATION OF THE SUPERIOR C6 HARDWARE. A CT SCAN OBTAINED ON (B)(6) 2024 CONFIRMED A SPINAL COMPRESSION FRACTURE AT C6 (COLLAPSE C6 VERTEBRAE).

  Patient problems: Neck Pain; Numbness; Vertebral Fracture

  MAUDE report 20605234 ↗
• InjuryNov 1, 2024Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SURGEON PERFORMED SECOND M6-C SURGERY ON HIS PATIENT. WHEN HE GOT ACCESS TO THE CERVICAL SPINE HE SAW THAT THERE IS SOMETHING WRONG WITH THE FIRST M6-C THAT HE HAD PUT IN 4 MONTHS AGO. THE CORE SEEMED UNSTABLE, THE SKIN OF THE CORE HAD LOOSENED AND THE ENDPLATES WERE SHIFTED IN AN UNUSUAL WAY. THERE WERE NO ISSUES WITH THE INSTRUMENTS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592928 ↗
• InjurySep 25, 2024Material Discolored; Scratched Material; Insufficient Device Problem Information; Ejection Problem; Material Discolored; Scratched Material; Insufficient Device Problem Information; Ejection Problem

  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: Bacterial Infection; Neck Pain; Osteolysis

  MAUDE report 20306482 ↗
• InjuryJun 27, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED STATES THERE WAS A REVISION WITH DR. (B)(6) ON (B)(6) 2024. PATIENT REPORTED SYMPTOMS OF DYSPHASIA AND AN INFECTION WAS SUSPECTED. SPECIMEN WAS SENT TO A LAB. WE RECEIVED ADDITIONAL INFORMATION FROM REP ON 6/5/2024: DR. (B)(6) INDICATED THERE MAY BE AN ALLERGIC REACTION INVOLVED. PATIENT HAD COMPLAINED OF DIFFICULTY SWALLOWING THREE WEEKS PRIOR AND IT CONTINUED TO WORSEN. PATIENT WAS PROGRESSING WELL UP UNTIL THAT TIME. TWO 6L M6-C HAD BEEN IMPLANTED ON (B)(6) 2020 AT C3-4AND C4-5 ADJACENT TO A PRIOR TWO LEVEL ACDF AT C5-6 AND C5-7. THE SURGEON WAS NOT CERTAIN WHAT THE REVISION PLAN WOULD BE UNTIL EXPOSURE WAS OBTAINED. ONCE INFECTION WAS SUSPECTED, TISSUE SAMPLES WERE OBTAINED AND SENT TO THE HOSPITAL LAB FOR CULTURES. AT THE REVISED C3-4 IMPLANT LEVEL, THERE WAS NO ANNULUS REMAINING, THE NUCLEUS WAS SHATTERED, AND THE ENDPLATES WERE INTACT. THERE APPEARED TO BE SOME OSTEOLYTIC CHANGES AT THE AFFECTED LEVEL C3-4. THE M6-C DISC AT THE C4-5 LEVEL WAS INTACT.

  Patient problems: Dysphasia; Unspecified Infection

  MAUDE report 19628678 ↗
• InjuryApr 3, 2024Collapse; Insufficient Device Problem Information; Collapse; Insufficient Device Problem Information

  DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Neck Pain

  MAUDE report 19032716 ↗
• MalfunctionFeb 23, 2024Fracture; Fracture

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C ARTIFICIAL CERVICAL DISC IMPLANTED AT C5-6 IN (B)(6) 2015. PATIENT FELT A SUDDEN POP AND NECK PAIN RADIATING DOWN HIS ARMS. IT WAS FOUND ON X-RAY THAT HIS C5-C6 ARTIFICIAL DISC HAD FAILED AND FRACTURED. FURTHER IMAGING REVEALED CENTRAL STENOSIS WITH CORD SIGNAL CHANGES AT C4-C5 ADJACENT TO HIS ARTIFICIAL DISC REPLACEMENT AS WELL AS OSTEOLYSIS SURROUNDING HIS DISC REPLACEMENT. THE M6-C WAS EXPLANTED AND REVISED WITH ACDF AT C4-C6 ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 18773214 ↗
• InjuryFeb 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C'S, ARTIFICIAL CERVICAL DISC, IMPLANTED AT LEVELS C5/6 - C6/7 AT AN UNKNOWN TIME. THE TWO DEVICES WERE EXPLANTED IN (B)(6) 2024 DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18718234 ↗
• InjuryFeb 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C'S, ARTIFICIAL CERVICAL DISC, IMPLANTED AT LEVELS C5/6 - C6/7 AT AN UNKNOWN TIME. THE TWO DEVICES WERE EXPLANTED IN (B)(6) 2024 DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18718233 ↗
• InjuryAug 30, 2023Material Separation; Material Separation

  INFORMATION PROVIDED STATES THAT PATIENT HAD AN M6-C DEVICE IMPLANTED AT LEVEL C5/6 IN (B)(6)2020. PATIENT EXPERIENCED RIGHT ARM RADICULOPATHY AND RADICULITIS AND C5/6 FORAMINAL STENOSIS. THE M6-C DEVICE WAS REMOVED AND REPLACED WITH A FUSION IN (B)(6) 2022.

  Patient problems: Limb Pain

  MAUDE report 17650260 ↗
• InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATED PATIENT HAD M6-C IMPLANTED AT C5/6 AND C6/7 IN (B)(6) 2017. THE PATIENT EXPERIENCED PAIN AND SWALLOWING DIFFICULTIES. THE DEVICE AT LEVEL C5/6 WAS REMOVED DUE TO SUSPECTED FOREIGN BODY, GRANULOMA IN (B)(6) 2023. THE DEVICE AT LEVEL C6/7 REMAINS IMPLANTED.

  Patient problems: Pain

  MAUDE report 17541071 ↗
• InjuryJul 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C4/5 ON (B)(6) 2021. THE PATIENT COMPLAINED OF INCREASING PAIN IN THE RIGHT SHOULDER AND RADIATED DOWN HER ARM. IMAGES SHOWED A SLIGHT ANTEROLISTHESIS OF C4/5 WITH SOME TILTING OF THE PROSTHESIS. THE PATIENT ALSO HAD DISC HERNITATIONS AT C7-T2 WHICH A FUSION WAS PERFORMED DUEING THE REMOVAL OF THE M6-C DEVICE. PATIENT IS CURRENTLY ON NSAIDS AND ANTIBIOTICS.

  Patient problems: Implant Pain; Neuropathy

  MAUDE report 17425284 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION PROVIDED STATES THAT AN M6-C ARTIFICIAL CERVICAL DISC WAS PLACED AT C5/6 IN 2021. THE DEVICE WAS REMOVED DUE TO FACET ARTHOPOTHY AND THE NEED FOR A GREATER DECOMPRESSION AT THE INDEX LEVEL. THE PATIENT HAD PRESENTED WITH 2 LEVEL SYMPTOMS RESULTING IN THE NEED FOR A FUSION AT C6/7 USING INTERBODY AND PLATE.

  Patient problems: Neck Pain

  MAUDE report 16729055 ↗
• InjuryAug 5, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT IMPLANTED WITH M6-C REPORTED PAIN. OSTEOLYSIS WAS DISCOVERED ON X-RAY. THE IMPLANT WAS REMOVED.

  Patient problems: Pain

  MAUDE report 15180508 ↗
• InjuryJul 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD NECK AND RADICULAR ARM PAIN. SURGEON REMOVED M6-C IMPLANT AND REPLACED WITH ACDF.

  Patient problems: Pain

  MAUDE report 15089427 ↗
• InjuryJul 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES PATIENT DEVELOPED RADICULAR PAIN THREE (3) WEEKS POST IMPLANT WITH DISPLAY OF SPONDYLOLISTHESIS AT C3-C4 OPERATIVE LEVEL. PT HAD PREVIOUS ACDF C5-C6 SIGNS OF AUTO FUSION AT C4-C5 LEVEL.

  Patient problems: Pain

  MAUDE report 15070978 ↗