ENDOSKELETON® TC nanoLOCK® Surface Technology 5146-1206-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191375012986), received between Mar 18, 2026 and Mar 18, 2026 — classified as 2 injuries.

4 other recalls cover devices cleared under the same FDA submission (K141953, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND INCIDENT TYPE AE SUBEVENT NUMBER: 001. PRIMARY DIAGNOSIS: STENOSIS ONSET DATE: 2025-10-13 OUTCOME DATE: (B)(6) 2025 OUTCOME STATUS: RECOVERED/ RESOLVED INTERVENTIONS: ACTION SUBTYPE: HOSPITALIZATION ACTION RESULT: NEW HOSPITALIZATION ACTION DATE: (B)(6) 2025 HOSPITALIZATION END DATE (B)(6) 2025 ACTION SUBTYPE: AE RESULT IN ANY TREATMENT ACTION RESULT: YES ACTION SUBTYPE: MEDICATION ADMINISTRATION ACTION RESULT: YES ANY OF THESE OPIATES OR NARCOTICS (ADJUSTED OR ADMINISTERED): NO SITE SERIOUSNESS ASSESSMENT: THERE IS HOSPITALIZATION AND NO CONGENITAL ANOMALY, DEATH, DISABILITY, LIFE THREATENING, MEDICAL OR SURGICAL INTERVENTION. SITE RELATED ASSESSMENT: IT IS NOT RELATED TO STUDY DEVICE AND POSSIBLE RELATED TO STUDY PROCEDURE (INDEX SURGERY). DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: DIAGNOSTIC TESTS PERFORMED ACTION RESULT: NO EVENT: IT WAS REPORTED THAT THE PATIENT HAD CERVICAL MYELOPATHY, NECK PAIN WITH SEVERE STENOSIS AT C5-7, NONUNION, FLAT NECK. FAILED CONSERVATIVE MANAGEMENT THEREFORE IN THE OUTPATIENT SETTING ELECTED PROCEE

  Patient problems: Spinal Cord Injury; Stenosis

  MAUDE report 24629077 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6), STUDY ID: (B)(4) AND INCIDENT TYPE AE SUBEVENT NUMBER: 001. PRIMARY DIAGNOSIS: STENOSIS ONSET DATE: ON (B)(6) 2025 OUTCOME DATE: ON (B)(6) 2025 OUTCOME STATUS: RECOVERED/ RESOLVED INTERVENTIONS: ACTION SUBTYPE: HOSPITALIZATION ACTION RESULT: NEW HOSPITALIZATION ACTION DATE: ON (B)(6) 2025 HOSPITALIZATION END DATE: ON (B)(6) 2025 ACTION SUBTYPE: AE RESULT IN ANY TREATMENT ACTION RESULT: YES ACTION SUBTYPE: MEDICATION ADMINISTRATION ACTION RESULT: YES ANY OF THESE OPIATES OR NARCOTICS (ADJUSTED OR ADMINISTERED): NO SITE SERIOUSNESS ASSESSMENT: THERE IS HOSPITALIZATION AND NO CONGENITAL ANOMALY, DEATH, DISABILITY, LIFE THREATENING, MEDICAL OR SURGICAL INTERVENTION. SITE RELATED ASSESSMENT: IT IS NOT RELATED TO STUDY DEVICE AND POSSIBLE RELATED TO STUDY PROCEDURE (INDEX SURGERY). DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: DIAGNOSTIC TESTS PERFORMED ACTION RESULT: NO EVENT: IT WAS REPORTED THAT THE PATIENT HAD CERVICAL MYELOPATHY, NECK PAIN WITH SEVERE STENOSIS AT C5-7, NONUNION, FLATNECK. FAILED CONSERVATIVE MANAGEMENT THEREFORE IN THE OUTPATIENT SETTING

  Patient problems: Spinal Cord Injury; Stenosis

  MAUDE report 24625432 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141953, 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-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