BLACKHAWK Cervical Spacer System S-TT10-1412C07Recalls & reported problems
Choice Spine, LP · BLACKHAWK TI,CON,STERILE,14WX12DX7HXC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996182201), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Migration; Migration
THE CAM OF THE BLACKHAWK TI IMPLANT DID NOT LOCK DURING THE INITIAL SURGERY. THE SURGEON NOTICED 4 WEEKS POST OP THAT ONE OF THE BLADES HAD BACKED OUT OF THE BONE. THE X RAY IMAGE INDICATED THAT A SCREW IN AN ADJACENT PLATE HAD PROHIBITED THE BLADES FROM BEING FULLY DEPLOYED AND NOT ALLOWING THE CAM TO LOCK APPROPRIATELY. ON (B)(6) 2025 A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW FROM THE ADJACENT CERVICAL PLATE TO ENABLE THE BLADE ON THE BLACKHAWK TI IMPLANT TO FULLY DEPLOY AND ALLOW THE CAM TO LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730127 ↗
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- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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