ENDOSKELETON® TAS nanoLOCK® Surface Technology 2312-0314-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375014270), received between Mar 12, 2020 and Mar 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K141953, K173535, 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 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  MEDTRONIC RECEIVED INFORMATION REGARDING A SPINAL DEVICE. IT WAS REPORTED THAT A SCREW BACKED OUT OF THE CAGE POST-OPERATIVELY. THE DATE OF THE PRIMARY SURGERY WAS (B)(6) 2019 AND THE DATE THE REPORTED ISSUE OCCURRED WAS (B)(6) 2019. THE PRIMARY SURGERY WAS PERFORMED TO TREAT A GRADE 1 MOBILE SLIP/ISTHMIC SPONDYLOLISTHESIS. THE LEVELS IMPLANTED WERE L5/S1. THE PATIENT RETURNED TO THE HOSPITAL A COUPLE OF WEEKS AFTER THE PRIMARY SURGERY WITH PAIN. IT WAS CONFIRMED BY IMAGING THAT A SCREW HAD BACKED OUT. AS A CAGE AND THREE SCREWS WERE USED, THE LOT NUMBER OF THE INDIVIDUAL SCREW THAT HAD BACKED OUT WAS UNABLE TO BE IDENTIFIED. THE PATIENT WAS READMITTED; THE PATIENT WAS BACKED UP WITH POSTERIOR PEDICLE SCREWS AND A POSTERIOR FUSION WAS COMPLETED TO STOP THE MOVEMENT OF THE CAGE. THE CAGE AND THREE SCREWS REMAINED IMPLANTED. IT WAS NOTED THAT THE SCREW THAT BACKED OUT WAS BEING MONITORED. AS THE CASE WAS NOT FAR ENOUGH OUT, FUSION HAD NOT BEEN ASSESSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 9826434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141953, K173535, 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