M6-C 6LLRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00812388030049), received between Jun 21, 2022 and Sep 23, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Insufficient Device Problem Information

  Patient problems: Osteolysis

  MAUDE report 50875089 ↗
• InjuryFeb 11, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 44 YEAR OLD FEMAL PATIENT HAD AN M6 CAGE REMOVED AS THEY HAD DEVELOPED OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 24315572 ↗
• InjuryJun 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ORTHOFIX RECEIVED A NOTIFICATION FROM THE FDA FOR REPORT MW5169519 THAT WAS RECEIVED THROUGH FDA MEDWATCH PROGRAM. THE REPORT DESCRIBES THE PROBLEM AS M6 FAILED IMPLANT. THE IMPLANT WAS "SPINNING" OUT. IMPLANT HAD TO BE SURGICALLY REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 22145554 ↗
• InjuryMay 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT C5/6 OSEOMYOLITIS SURGEON CHANGED OUT FOR CAGE AND PLATE TO ACHIEVE FUSION AT SITE. OSTEOMYOLITIS WAS NOTED AT SUPERIOR AND INFERIOR ENDPLATES. INFECTION WAS PRESENT - OBSERVATION OF OSTEOMYELITIS ON PRE OP MRI AND X-RAY (IDENTIFIED BY SURGEON BUT NOT SHARED TO ATTENDING REP, IMPLANT NOT AVAILABLE TO RETURN)).

  Patient problems: Osteomyelitis

  MAUDE report 22057093 ↗
• InjuryApr 11, 2025Collapse; Material Integrity Problem; Insufficient Device Problem Information; Collapse; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISC FAILURE UNDERWENT ADDITIONAL LEVEL FUSION. C5-6 M6C IN SITU, REMOVED AND REPLACED WITH CAGE AND NEW PLATE TO COVER C5-7 (C6-7 ALREADY FUSED).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 21829827 ↗
• InjuryJan 21, 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 THAT DR EXPLANTED AN M6 AND CONVERTED IT TO A FUSION. PATIENT WAS ADMITTED FOR INFECTION OF THE DEVICE. IT WAS REPORTED THAT THE DEVICE CORE WAS FRAYED. OSTEOLYSIS WAS NOTED ON THE FORM.

  Patient problems: Medical device site infection; Osteolysis

  MAUDE report 21200339 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REMOVAL OF MC6 FROM PATIENT TODAY BY DR DUE TO PERSISTENT NECK PAIN. DR WAS ABLE TO REMOVE IMPLANT WHOLE WITH ONLY LIMITED DAMAGE TO INNER SHEATH DUE TO DRILL. DISC LOOKS IN GOOD CONDITION AND NO SIGNS OF OSTEOLYSIS

  Patient problems: Neck Pain

  MAUDE report 20592490 ↗
• InjuryNov 1, 2024Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED: OP: C4/5 TDR (PRO-DISC) + REPLACEMENT (REVISION) OF C5/6+C6/7 M6C - REPLACING WITH PRISM BOREALIS AUILIA ACDF IMPLANTS. OSTEOLYSIS DIAGNOSIS AND MECHANICAL FAILURE OF THE PROSTHESIS ON BOTH LEVELS C5/6+ C6/7 . IMPLANTATION TIME FRAME 1ST - (ESTIMATE YEAR- 2015) C6/7 - IMPLANTED IN WA 2ND - (ESTIMATE YEAR- 2017) C5/6 - IMPLANTED BY J. PAPACOSTAS - QLD . FINDINGS DURING REMOVAL -FOUND A BIG GRANULOMA IN FRONT OF C5/6. SAMPLE TAKEN AND SENT TO PATHOLOGY ( C5/6 GRANULATION TISSUE). REMOVED C6/7 FIRST (IN PARTS) FOLLOWED BY C 5/6. (INTACT IMPLANT)

  Patient problems: Granuloma; Osteolysis

  MAUDE report 20592434 ↗
• InjuryNov 1, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED: OP: C4/5 TDR (PRO-DISC) + REPLACEMENT (REVISION) OF C5/6+C6/7 M6C - REPLACING WITH PRISM BOREALIS AUILIA ACDF IMPLANTS. OSTEOLYSIS DIAGNOSIS AND MECHANICAL FAILURE OF THE PROSTHESIS ON BOTH LEVELS C5/6+ C6/7. IMPLANTATION TIME FRAME. 1ST - (ESTIMATE YEAR- 2015) C6/7 - IMPLANTED IN (B)(6). 2ND - (ESTIMATE YEAR- 2017) C5/6 - IMPLANTED BY (B)(6). FINDINGS DURING REMOVAL -FOUND A BIG GRANULOMA IN FRONT OF C5/6. SAMPLE TAKEN AND SENT TO PATHOLOGY (C5/6 GRANULATION TISSUE). REMOVED C6/7 FIRST (IN PARTS) FOLLOWED BY C 5/6 (INTACT IMPLANT).

  Patient problems: Granuloma; Osteolysis

  MAUDE report 20592263 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT DEVELOPED SEVERE OSTEOLYSIS. FIRST ATTEMPT TO REVISE AND RELIVE PRESSURE ON THE CORD WAS DONE BY LAMINOPLASTY AT C3/4/6 LEVEL EARLIER THIS YEAR. DATE TBA. DOCTOR MADE THE DECISION TO REMOVE THE FAILED DISC AND FUSE C4/6 LEVEL. C5/6 LEVEL STILL INTACT SO IT WAS NOT REVISED. PATIENT DEVELOPED PAIN AND WEAKNESS AND A CT REVEALED A FAILED M6-C DEVICE AND OSTEOLYSIS AT C3/4. IT WAS REVISED AND FUSED WITH A CAGE AND PLATE.

  Patient problems: Osteolysis; Pain

  MAUDE report 19513637 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED DISC AT 5/6 HAD SIGN OF RUPTURE BUT IT'S DIFFICULT TO TELL WHAT THE STATE OF THE DISC WAS IN IN-SITU AS SURGEON CAUSES FURTHER DAMAGE TO THE DISC TO GET IT OUT. PATIENT ASYMPTOMATIC BUT OSTEOLYSIS PICKED UP ON ROUTINE FOLLOW UP IMAGING THE NSI GROUP ALL DO HERE NOW. C5/6 AND C6/7 FOREIGN BODY OSTEOLYSIS. DOCTOR PERFORMED C5/6-C6/7 SUBTOTAL VERTEBRECTOMY AND R/O M6-C (X2). REDO C5/6 AND C6/7 DECOMPRESSION ILIAC CREST GRAFT RECONSTRUCTION. C5/6-C6/7 FIXATION. PER OP REPORT: BOTH IMPLANTS MOBILE AND EXPLANTED. RPH HISTOLOGY MULTIPLE SAMPLES OF TISSUE FROM OSTEOLYSIS CYST.

  Patient problems: Osteolysis

  MAUDE report 19512468 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED DISC AT 5/6 HAD SIGN OF RUPTURE BUT IT'S DIFFICULT TO TELL WHAT THE STATE OF THE DISC WAS IN IN-SITU AS SURGEON CAUSES FURTHER DAMAGE TO THE DISC TO GET IT OUT. PATIENT ASYMPTOMATIC BUT OSTEOLYSIS PICKED UP ON ROUTINE FOLLOW UP IMAGING THE NSI GROUP ALL DO HERE NOW. C5/6 AND C6/7 FOREIGN BODY OSTEOLYSIS. DOCTOR PERFORMED C5/6-C6/7 SUBTOTAL VERTEBRECTOMY AND R/O M6-C (X2). REDO C5/6 AND C6/7 DECOMPRESSION ILIAC CREST GRAFT RECONSTRUCTION. C5/6-C6/7 FIXATION. PER OP REPORT: BOTH IMPLANTS MOBILE AND EXPLANTED. RPH HISTOLOGY MULTIPLE SAMPLES OF TISSUE FROM OSTEOLYSIS CYST.

  Patient problems: Osteolysis

  MAUDE report 19512152 ↗
• InjuryJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THERE WAS A REMOVAL OF AN M6-C DEVICE AT C6/7. SURGEON ORIGIONALLY THOUGHT OSTEOLYSIS PRESENT BUT UPON COMMENCEMENT OF THE PROCEDURE HE NOW THINKS INFECTION WAS THE CAUSE. THERE WAS A LARGE COLLECTION OF PUS. PATIENT HAS A 2 LEVEL M6 IMPLANTED ON (B)(6) 2024 AT C5/6-C6/7 BUT ONLY THE LOWER LEVEL WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 19469429 ↗
• InjuryMay 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED STATES: THE PATIENT IS A 64-YEAR-OLD FEMALE WHO PRESENTS WITH A HISTORY OF OSTEOLYSIS SURROUNDING C6/7 DISC PROSTHESIS. SHE ALSO HAS A DISC LESION AT C5/6. THERE IS EVIDENCE OF FIBROSIS, CHRONIC INFLAMMATION COMPRISING PREDOMINANTLY LYMPHOCYTES AS WELL AS NUMEROUS MACROPHAGES. THE MACROPHAGES CONTAIN METAL PARTICLES IN THE CYTOPLASM WHICH ARE NON REFRACTILE (METALLOSIS). THERE IS NO EVIDENCE OF SUPPURATION AND NO EVIDENCE OF A NEOPLASTIC POPULATION. INFECTIVE ORGANISMS ARE NOT NOTED. THE PATIENT COMPLAINED OF SEVERE HEADACHES, LEFT ARM PAIN AND AN INABILITY TO EXTEND HER NECK FOR ABOUT 18 MONTHS. HER SLEEP WAS AFFECTED BY THE PAIN. CLINICALLY THE PATIENT HAD MYELOPATHIC SIGNS WITH SEVERE WEAKNESS IN HER LEFT HAND. XRAYS AND CT SHOWED THAT THE CORE OF THE M6 DEVICE AT C6.7 HAD DISSOLVED AND THERE WAS EXTENSIVE OSTEOLYSIS IN THE SURROUNDING VERTEBRAE AT C6. AND C7. THE MRI SHOWED A DISC HERNIATION AT THE C5.6 LEVEL WITH SPINAL CORD COMPRESSION AND SIGNAL CHANGES IN THE SPINAL CORD. THE PATIENT HAD SURGERY ON (B)(6) 2024 AND THE M6 DEVICE WAS REMOVED AT C6.7, DISCECTOMY C5.6 AND C 6 CORPECTOMY PERFORMED WITH FUSION C5-7.

  Patient problems: Fibrosis; Headache; Inflammation; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 19231579 ↗
• InjuryMay 2, 2024Collapse; Insufficient Device Problem Information; Collapse; Insufficient Device Problem Information

  INFORMATION RECEIVED STATES: THE PATIENT IS A 64-YEAR-OLD FEMALE WHO PRESENTS WITH A HISTORY OF OSTEOLYSIS SURROUNDING C6/7 DISC PROSTHESIS. SHE ALSO HAS A DISC LESION AT C5/6. THERE IS EVIDENCE OF FIBROSIS, CHRONIC INFLAMMATION COMPRISING PREDOMINANTLY LYMPHOCYTES AS WELL AS NUMEROUS MACROPHAGES. THE MACROPHAGES CONTAIN METAL PARTICLES IN THE CYTOPLASM WHICH ARE NON REFRACTILE (METALLOSIS). THERE IS NO EVIDENCE OF SUPPURATION AND NO EVIDENCE OF A NEOPLASTIC POPULATION. INFECTIVE ORGANISMS ARE NOT NOTED. THE PATIENT COMPLAINED OF SEVERE HEADACHES, LEFT ARM PAIN AND AN INABILITY TO EXTEND HER NECK FOR ABOUT 18 MONTHS. HER SLEEP WAS AFFECTED BY THE PAIN. CLINICALLY THE PATIENT HAD MYELOPATHIC SIGNS WITH SEVERE WEAKNESS IN HER LEFT HAND. XRAYS AND CT SHOWED THAT THE CORE OF THE M6 DEVICE AT C6.7 HAD DISSOLVED AND THERE WAS EXTENSIVE OSTEOLYSIS IN THE SURROUNDING VERTEBRAE AT C6. AND C7. THE MRI SHOWED A DISC HERNIATION AT THE C5.6 LEVEL WITH SPINAL CORD COMPRESSION AND SIGNAL CHANGES IN THE SPINAL CORD. THE PATIENT HAD SURGERY ON (B)(6) 2024 AND THE M6 DEVICE WAS REMOVED AT C6.7, DISCECTOMY C5.6 AND C 6 CORPECTOMY PERFORMED WITH FUSION C5-7.

  Patient problems: Fibrosis; Headache; Inflammation; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 19231385 ↗
• InjuryApr 3, 2024Collapse; Insufficient Device Problem Information; Collapse; Insufficient Device Problem Information

  DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19032975 ↗
• InjuryMar 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVCIE WAS RETURNED FOR INVESTIGATION.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18870860 ↗
• InjuryMar 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DEVICE WAS RETURNED FOR INVESTIGATION.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 18870739 ↗
• InjuryJan 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C TDR IMPLANTED AT C4/5 IN (B)(6) 2020. PATIENT EXPERIENCED PAIN, WITH SUSPECTED OSTEOLYISIS. THE SURGEON REMOVED THE M6-C AND REPLACED WITH ACDF AT C4/5.

  Patient problems: Pain

  MAUDE report 18480981 ↗
• InjuryDec 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT UNKNOWN LEVEL ON (B)(6), 2023. THE PROPER PROCEDURE FOR THIS PATIENT WAS TO BE AN ACDF AND A TDR (M6) HAS PROVEN TO BE INEFFECTIVE. NO OTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18253295 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C4/5 IN (B)(6) 2019. THE DEVICE WAS EXPLANTED IN (B)(6) 2023 DUE TO SUSPECTED OSTEOLYSIS. SWELLING AND DYSPHASIA WAS NOTICED AT THE TIME OF DEVICE REMOVAL.

  Patient problems: Osteolysis

  MAUDE report 18235184 ↗
• InjuryNov 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT AN M6-C WAS IMPLANTED IN 2017 AT C5/6. THE DEVICE WAS EXPLANTED IN (B)(6) 2023 DUE TO PATIENT EXPERIENCED NECK PAIN, NUMBNESS IN LEFT ARM, TINGLING INTO FINGERS AND HEADACHES. X-RAYS REVEALED LYSIS AND SUBSIDENCE. THE VETREBRAL BODY ABOVE THE IMPLANT WAS SOFT AND UNABLE TO TAKE ACDF SCREW. STATUS OF PATIENT IS STANDARD POST-OP AND SOFT COLLAR.

  Patient problems: Neck Pain; Numbness; Paresthesia

  MAUDE report 18179386 ↗
• InjurySep 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C6/7 IN (B)(6) 2021. PATIENT BEGAN EXPERIENCING DIFFICULTY SWALLOWING DUE TO PREVERTEBRAL ABCESS AND PHLEGMONOUS MASS EXTENDING FROM C2 TO T7. THE ABCESS MEASURED 6 X 2.4 CM AT THE C7 LEVEL AFFECTING THE PHARYNX. THE M6-C DEVICE WAS REMOVED. PATIENT IS BEING TREATED POST-OPERATIVELY WITH SOFT CERVICAL COLLAR, ANTIBIOTICS, MUSCLE RELAXANTS AND POST OP PHYSICAL THERAPY.

  Patient problems: Abscess

  MAUDE report 17778344 ↗
• InjuryAug 22, 2023Collapse; Collapse

  INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C IMPLANTED AT C5/6 IN (B)(6) 2019. PATIENT EXPERIENCED A FALL IN MID 2022. THE IMAGES SHOWED SUBSIDENCE OF THE DEVICE INTO THE C6 VERTEBRA AND NON-UNION OF THE FUSION AT THE C6/7 LEVEL. PATIENT EXPERIENCED PAIN IN HIS RIGHT PARASCAPULAR AREA AND SHOULDER.

  Patient problems: Pain

  MAUDE report 17595270 ↗
• InjuryAug 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED STATES THAT TWO (2) M6-C DEVICES WERE EXPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17595268 ↗