ENDOSKELETON® TCS 5210-1021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191375011873), received between Feb 21, 2018 and May 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K142940); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR ANTERIOR CER VICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS NO LONGER HOLDING THE IMPLANT SECURELY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199542 ↗
• MalfunctionFeb 21, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING AN ACF C5-C6 LEVEL SURGERY, THE SURGEON HAD SOME TROUBLE DISENGAGING AN IMPLANT. THE SURGEON EXPERIENCED CROSS THREADING BETWEEN THE THREADED INSERTER AND THE IMPLANT, MAKING THE DISENGAGEMENT BETWEEN THE TWO DIFFICULT. ONCE THE SURGEON DISENGAGED THE IMPLANT, HE DID NOT LIKE THE FIT OF THE IMPLANT INSIDE THE PATIENT'S DISC SPACE. THE SURGEON REMOVED THAT IMPLANT AND USED ANOTHER IMPLANT INSTEAD WHICH WAS SATISFACTORY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142940. One submission often covers many models, so check the product and lot details in each record.

• Z-2327-2015 · Jul 20, 2015 · Terminated
  Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514
• Z-1324-2015 · Feb 20, 2015 · Terminated
  Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with