BLACKHAWK Cervical Spacer System S-TT10-1614606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996182256), received between May 12, 2023 and May 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 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.

• MalfunctionMay 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  DR. (B)(6) DID A REVISION CASE ON (B)(6) 2023 FROM THE ORIGINAL CASE ON (B)(6) 2023 (COMPLAINT (B)(4) ). DR. (B)(6) USED GENERAL HOSPITAL INSTRUMENTATION TO REMOVE THE BLADE THAT WAS BACKING OUT OF THE CAGE. HE WAS ABLE TO GET THE BLADE FULLY REMOVED WHILE REMOVING THE BLADE HE ALSO REMOVED THE CAM FROM THE CAGE. DR. (B)(6) LEFT THE ORIGINAL IMPLANT IN WITH ONE BLADE DEPLOYED.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 16918268 ↗