M6-C 7MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812388030056), received between Apr 27, 2023 and Nov 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Collapse” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Collapse; Collapse

  INFORMATION PROVIDED STATES THAT PATIENT HAD AN M6-C IMPLANTED AT C5/6 IN 2017. THE PATIENT EXPERIENCED PAIN AND SPINAL CORD SIGNAL CHANGE. THE M6-C APPEARED TO BE COLLAPSED AND WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 18115807 ↗
• InjuryApr 27, 2023Collapse; Insufficient Device Problem Information; Collapse; 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. ADDITIONAL INFORMATION STATES THAT THE TW M6-C DISCS WERE IMPLANTED AT C5/6 AND C6/7.

  Patient problems: Insufficient Information

  MAUDE report 16828404 ↗