ENDOSKELETON® TO nanoLOCK® Surface Technology 3114-2211-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375013518), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

Recent adverse event reports

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

• InjuryMar 29, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR CAGE PROTRUSION WAS OBSERVED NEAR THE POSTERIOR WALL OF L4/5. PROCEDURE OR THERAPY PERFORMED WAS L3/5 TLIF THERAPY. IT WAS REPORTED THAT THE CAGE OF L4/5 WAS REMOVED BECAUSE IT WAS COMING OUT BACKWARD AND MAY CAUSE NEUROLOGICAL SYMPTOMS IN THE FUTURE. AFTER REMOVING THE PROTRUDING CAGE ON MARCH 10. CAGE MOVED BACKWARD DURING L4/5 PLACEMENT. IT WAS REMOVED BEFORE IT CAME IN CONTACT WITH THE DURA MATER. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633500 ↗

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