ENDOSKELETON TCS 5210-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682521010050), received between Jan 28, 2016 and Jan 28, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. 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.

• MalfunctionJan 28, 2016Break; Nonstandard Device

  THE SURGEON WAS PERFORMING A CERVICAL FUSION PROCEDURE AT C6-C7. THE SURGEON FOLLOWED THE CORRECT PROCEDURE BY UTILIZING THE PUNCH AWL BEFORE PLACING THE SCREW. THE PUNCH AWL ANGLE TRAJECTORY AND DEPTH WAS ANALYZED UNDER FLUORO. A TCS SWIVEL HEX DRIVER WAS USED TO INSERT A 3.5MM X 14MM LOCKING SCREW INTO C6. DURING FINAL X-RAY, THE CAGE AND TWO SCREW CONSTRUCT WERE IDENTIFIED AS BEING PLACED TOO OFF MIDLINE TO THE PATIENT ANATOMY. THE SURGEON WENT TO REMOVE THE SCREW IN C6; HOWEVER, THE SURGEON COULD NOT RE-ENGAGE THE HEX DRIVER INTO THE SCREW HEAD. UNDER THE MICROSCOPE, THE SURGEON IDENTIFIED THE DISTAL TIP OF THE HEX DRIVER HAD PARTIALLY BROKEN OFF INTO THE SCREW HEAD. THE IMPLANT WAS REMOVED BY THE SURGEON BURRING THE BONE OF THE C6 VERTEBRAE DIRECTLY ABOVE THE SCREW HOLE. THE REMOVAL OF BONE ANTERIOR TO THE SCREW ALLOWED THE SURGEON TO REMOVE THE IMPLANT DEVICE WITH THE SCREW STILL ENGAGED. THE PROCEDURE WAS FINISHED USING ANOTHER CERVICAL STANDALONE SYSTEM. NO ADVERSE EFFECTS OR INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5397347 ↗

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