BLACKHAWK Cervical Spacer System S-TT10-1614608Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996182270), received between Aug 1, 2023 and Aug 1, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Collision” (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.

• MalfunctionAug 1, 2023Unintended Collision; Unintended Collision

  DR. (B)(6) WAS DOING A ACDF PROCEDURE WITH HARDWARE (PLATE AND SCREWS) ALREADY IN THE PATIENT. HE EXPRESSED DIFFICULTY GETTING THE CAUDAL ANCHOR IMPACTED WHERE THE EXISTING HARDWARE WAS. THE REP ( (B)(6) ) CALLED (B)(6) WHILE IN THE CASE AND (B)(6) INSTRUCTED THEM TO USE THE SINGLE ANCHOR IMPACTOR TO HELP THE BLADE DEPLOY. DR. (B)(6) WAS ABLE TO GET BOTH BLADES DEPLOYED AND THE CAM TURNED FOR FINAL LOCKING. (B)(6) EXPRESSED HE DIDN'T THINK THE CAM WAS FULL LOCKED DUE TO HOW HARD IT WAS TO GET THE ANCHOR FULLY DEPLOYED. DR. (B)(6) DID A REVISION ON THE PATIENT (B)(6) 2023 USING A GLOBUS MEDICAL CAGE AND PLATE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17439382 ↗