CAPSTONE PTC™ Spinal System 3992609Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169187436), received between Sep 22, 2026 and Sep 28, 2026 — classified as 2 malfunctions.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem; Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915242 ↗
• MalfunctionSep 22, 2026Mechanics Altered

  Information was received from the distibutor via a manufacturer representative regarding a device used for Minimally Invasive Transf oraminal Lumbar Interbody Fusion procedure. It was reported that during intra-op, the threaded connection spun freely without engaging or tightening, which prevented the cage from locking securely onto the insertion tool, and the original cage was set aside and qua rantined while a new implant was opened, which threaded and locked onto the inserter without issue.The procedure was completed successfully without patient injury. There were no patient symptoms reported. There were no further complications reported regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850795 ↗