ENDOSKELETON TCS nanoLOCK Surface TechnologyRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of ENDOSKELETON TCS nanoLOCK Surface Technology by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 23, 2025 and Feb 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ENDOSKELETON TCS nanoLOCK Surface Technology recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 2, 2021Terminated
Engraving on implants may not match what is listed on the pouch labels.
Z-0086-2022 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported ENDOSKELETON TCS nanoLOCK Surface Technology problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
ENDOSKELETON TCS nanoLOCK Surface Technology models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1410-NIntervertebral fusion device with integrated fixation, lumbar1 recall0 reports
- ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1406-NIntervertebral fusion device with integrated fixation, cervical1 report
Recent ENDOSKELETON TCS nanoLOCK Surface Technology adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2025Break; Break
INFORMATION WAS RECEIVED FROM A REGULATORY BODY, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN, METAL REMOVED FROM PATIENT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442917 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page