Endoskeleton TAS 2312-0112-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M68223120112N0), received between Feb 24, 2017 and Feb 24, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K111626, 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.

• MalfunctionFeb 24, 2017Device Operates Differently Than Expected

  DURING A SCOLI DEFORMITY CORRECTION THE SURGEON WAS DOING AN ALIF L4/L5 PROCEDURE, SOMEHOW DROVE THE SCREW THROUGH THE BACK OF THE IMPLANT AND WERE NOT ABLE TO BACK THE SCREW OUT. SURGEON ATTEMPTED TO BACK OUT THE CAGE WITH THE SCREW IN PLACE. DURING THE PROCESS SOMETHING VASCULAR WAS NICKED, THE VASCULAR SURGEON CLAMPED THE VESSEL AND WAS ABLE TO STOP THE BLEEDING. SURGEON WAS ABLE TO PUT IN ANOTHER CAGE AND COMPLETE THE PROCEDURE. THE VASCULAR SURGEON CLOSED THE PATIENT AND THE SURGERY WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury

  MAUDE report 6358609 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111626, 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