COLORADO 2™ Spinal System 8638535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902070525), received between Nov 14, 2017 and Nov 14, 2017 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K991031); 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 16, 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.

• MalfunctionNov 14, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT T2-T12 DUE TO SCOLIOSIS. REPORTEDLY, THE IMPLANTS BROKE DURING THE SURGERY. WHEN THE SURGEON WANTED TO LOCK THE NUT ON T8 THE POST OF THE SCREW BROKE OFF AT THE HEXAGONAL HEAD OF THE SCREW. THE SCREW WAS EXPLANTED COMPLETELY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7030248 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991031. One submission often covers many models, so check the product and lot details in each record.

• Z-0125-2008 · Sep 10, 2007 · Terminated
  Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.