ENDOSKELETON® TC 5166-1408Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375003663), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K100889, 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 16, 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.

• InjuryJun 27, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED BY THE SURGEON THAT THE OPERATED LEVEL WAS NOT FUSED AT THE ONE YEAR FOLLOW UP AND THAT THE IMPLANT SUBSIDED INTO BOTH OF THE VERTEBRAL BODIES ADJACENT TO THE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739807 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100889, K183557, K192018. One submission often covers many models, so check the product and lot details in each record.

• Z-0086-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
• Z-0085-2022 · Sep 2, 2021 · Terminated
  Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
• 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