ENDOSKELETON® TCS 5302-3518Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375011545), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K151596); 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 16, 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.

• MalfunctionFeb 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING COLLAR FELL OFF THE SCREW BODY AND COULD NOT BE USED WHILE INSERTING THE SCREW. A DIFFERENT SCREW WAS ABLE TO BE USED AND THE PLANNED C5/6 PROCEDURE WAS ABLE TO BE COMPLETED. THE SCREW WAS DISCARDED AT THE HOSPITAL. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290499 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151596. 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