BLACKHAWK Cervical Spacer System S-TT10-1412606Recalls & reported problems
Choice Spine, LP · BLACKHAWK TI,LOR,STERILE,14WX12DX6H · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840996182133), received between Apr 14, 2026 and Aug 4, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Migration1
Patient problems
- Neck Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026Migration
Patient problems: Neck Pain
MAUDE report 50126973 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
DR. TOOK X-RAY IMAGES OF PATIENT AT FOLLOW-UP APPOINTMENT WHEN IT WAS NOTICED THAT THE LOCKING PLATE BECAME DETACHED FROM THE IMPLANT. DR. REVISED THE PATIENT ON (B)(6) 2026 BY PLACING A PLATE OVER THE CAGE AND REMOVING THE DETACHED LOCKING PLATE FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877114 ↗
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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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