ENDOSKELETON® TC nanoLOCK® Surface Technology 5166-1405-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375013051), received between Oct 21, 2025 and Oct 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K141953, K183557, K192018); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT THE HWK 3/4 LEVEL FOR AN INDICATION OF HERNIATED DISC AT HWK 3/4. IT WAS REPORTED THAT THE CAGE BECAME LOOSE AND SLIPPED, AND THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE CAGE. THE PATIENT WAS HAVING SLIGHT DISCOMFORT WHEN SWALLOWING AS A RESULT OF THIS EVENT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 23345589 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141953, K183557, K192018. One submission often covers many models, so check the product and lot details in each record.

• Z-0085-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
• Z-0086-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
• Z-1439-2021 · Mar 17, 2021 · Terminated
  Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental f
• Z-1440-2021 · Mar 17, 2021 · Terminated
  Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental f