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ENDOSKELETON® TO nanoLOCK® Surface Technology 3114-2611-NRecalls & reported problems

Medtronic Sofamor Danek, Inc. · Interbody Fusion Device 4 Degree PLIF 11mm · 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 00191375013600), received between Sep 6, 2019 and Sep 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Expulsion” (1 report).

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

  • Expulsion1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjurySep 6, 2019Expulsion; Expulsion

    AT A FOLLOW-UP WITH A PATIENT WHO RECEIVED AN ENDOSKELETON® TO IMPLANT ON (B)(6) 2019 (DATE OF ORIGINAL SURGERY), IT WAS IDENTIFIED THAT THE CAGE MIGRATED OUTSIDE THE DISC SPACE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8969616 ↗

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-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

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Sources and updates

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