M6-C 7LLRecalls & reported problems
Spinal Kinetics, Inc. · Artificial Cervical Disc, 7LL (7mm H x 17mm W x 16mm D) · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812388030087), received between Apr 6, 2023 and Nov 21, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Collapse1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Implant Pain1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 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 SURGERY WAS PERFORMED TO REMOVE ONE DEFECTIVE M6-C THAT WAS IMPLANTED 2 YEARS AGO ON (B)(6) 2021.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Unspecified Infection
MAUDE report 20748570 ↗InjuryJan 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION PROVIDED STATES THAT PATIENT HAD M6-C ARTIFICIAL CERVICAL DISC IMPLANTED AT LEVEL C6/7 IN (B)(6) 2018. THE PATIENT RECENTLY BEGAN EXPERIENCING RADICULAR PAIN RESULTING IN THE REMOVAL OF THE DISC. THE SURGEON PERFORMED A CORPECTOMY AND FUSION.
Patient problems: Pain
MAUDE report 18441530 ↗InjuryApr 6, 2023Collapse; Collapse
INFORMATION PROVIDED STATES THAT PATIENT HAD AN M6-C DEVICE IMPLANTED AT C6/7 AND AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C7/T1. THE PATIENT BEGAN EXPERIENCING PAIN AND DISCOMFORT. RADIOGRAPHIC IMAGING SHOWED THE M6-C DISC HAD COLLAPSED. A REVISION SURGERY WAS PERFORMED TO REMOVE THE DISC.
Patient problems: Implant Pain
MAUDE report 16690546 ↗
Other Prosthesis, Intervertebral Disc devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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