ENDOSKELETON TC nanoLOCK Surface TechnologyRecalls & reported problems across all models

We found 6 models of ENDOSKELETON TC nanoLOCK Surface Technology by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2025 and Mar 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ENDOSKELETON TC nanoLOCK Surface Technology recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 17, 2021Terminated

   The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

   Z-1440-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Mar 17, 2021Terminated

   The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

   Z-1439-2021 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported ENDOSKELETON TC nanoLOCK Surface Technology problems

ENDOSKELETON TC nanoLOCK Surface Technology models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENDOSKELETON® TC nanoLOCK® Surface Technology 5146-1208-N

  Intervertebral fusion device with bone graft, cervical
  1 recall0 reports
• ENDOSKELETON® TC nanoLOCK® Surface Technology 5186-1608-N

  Intervertebral fusion device with bone graft, cervical
  1 recall0 reports
• ENDOSKELETON® TC nanoLOCK® Surface Technology 5146-1206-N

  Intervertebral fusion device with bone graft, cervical
  2 reports
• ENDOSKELETON® TC nanoLOCK® Surface Technology 5166-1405-N

  Intervertebral fusion device with bone graft, cervical
  1 report
• ENDOSKELETON® TC nanoLOCK® Surface Technology 5166-1406-N

  Intervertebral fusion device with bone graft, cervical
  1 report
• ENDOSKELETON® TC nanoLOCK® Surface Technology 5166-1407-N

  Intervertebral fusion device with bone graft, cervical
  1 report

Recent ENDOSKELETON TC nanoLOCK Surface Technology adverse event reports

The 5 most recent reports across all models, 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 ↗
• InjuryOct 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354888 ↗
• InjuryOct 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354879 ↗
• InjuryOct 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE AT THE HWK 3/4 LEVEL FOR AN INDICATION OF HERNIATED DISC AT HWK 3/4. IT WAS REPORTED THAT THE CAGE BECAME LOOSE AND SLIPPED, AND THE PATIENT DID NOT ACHIEVE SOLID FUSION. THE ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE CAGE. THE PATIENT WAS HAVING SLIGHT DISCOMFORT WHEN SWALLOWING AS A RESULT OF THIS EVENT.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 23345589 ↗

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