Endoskeleton TT 4114-3009-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M68241143009N0), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K083714, K141953); 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.

• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS EXPLANTED, BECAUSE THE PATIENT COMPLAINED OF PAIN. UPON REVIEW, IT WAS IDENTIFIED THAT THERE WAS NO FUSION PRESENT.

  Patient problems: Pain

  MAUDE report 7626457 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083714, K141953. 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-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