ENDOSKELETON® TCS 5301-3814Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375011422), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE DR WAS INSERTING THE FINAL TCS STANDARD SCREW INTO THE PATIENT WHEN HE NOTICED THAT HT ESCREW WAS "HOLLOWING" AND MAKING THE HOLE LARGER INSTEAD OF HOLDING IN PLACE. THE DR. DECIDED TO REMOVE THE SCREW FROM THE PATIENT AND WITH MUCH DIFFICULTY WAS FINALLY ABLE TO DO SO. THE SURGEON COMPLETED THE PLANNED PROCEDURE BUT HE DID NOT INSERT A NEW SCREW WHERE HE HAD REMOVED THE ONE WHICH WAS NOT HOLDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287295 ↗

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