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ENDOSKELETON® TO nanoLOCK® Surface Technology 3110-3110-NRecalls & reported problems

Medtronic Sofamor Danek, Inc. · Interbody Fusion Device 0 Degree Convex Oblique 10mm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375013419), received between Apr 2, 2019 and Apr 2, 2019 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K141953, K170399, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE COMPLAINANT ALLEGED THAT THE SUBJECT DEVICE MIGRATED POSTERIORLY, LEADING TO A REVISION SURGERY. INITIAL SURGERY: (B)(6) 2018, REVISION SURGERY: (B)(6) 2019.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8474499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141953, K170399, 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-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
  • 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

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page