ENDOSKELETON TCS 5210-1004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M682521010040), 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; Detachment Of Device Component; Nonstandard Device

  THE DRIVER TIP SHEARED OFF INSIDE THE SCREW HEAD AT THE POINT OF CONTACT WITH THE HEX DRIVE FEATURE. THE TIP OF THE DRIVER WAS REMOVED FROM THE SCREW USING A NEEDLE NOSE PLIERS. PROCEDURE WAS COMPLETED WITH NO INJURY OR ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5397013 ↗

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