ENDOSKELETON® TCS 5301-3516Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191375011361), received between Jul 14, 2020 and Jul 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 14, 2020Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH FUSION THERAPY. IT WAS REPORTED THAT, THE SURGEON WENT TO IMPLANT THE SCREW HE NOTICED A HAIRLIKE PIECE OF METAL. HE STOPPED IMPLANTING THE SCREW AND REVERSED THE SCREW TO NOTICE THAT PART OF THE PROXIMAL THREAD HAD SHEARED OFF. HE THOUGHT THAT HIS PILOT HOLE WAS NOT FOLLOWED AND THE THREAD WAS RUBBING ON THE IMPLANT AND THUS CAUSED IT TO DELAMINATE UPON ENTRY. THE PIECE WAS INTACT AND DISCARDED, BUT THE SCREW WAS RETAINED AFTER A DISINFECTANT WASHING IN SPD. THERE WAS NO FRAGMENT LEFT OR CONTACT WITH THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10269094 ↗

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