Hive Standalone Cervical System 08-A-2006-4006Recalls & reported problems
Nanohive Medical LLC · 18Wx14Lx6H, 6° Zero Profile - Tube Package Configuration · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817493024921), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- 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.
InjuryJul 31, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
ON 7/2/2025, THIRD PARTY AGENT REPORTED TO NANOHIVE THAT DURING A ROUTINE 2-WEEK POST-OP FOLLOW UP ON (B)(6) 2025, RADIOGRAPH IMAGING REVEALED THE COVER PLATE WAS FOUND TO BE PARTIALLY DISLOCATED FROM THE INTERBODY. A PATIENT X-RAY TAKEN DURING THE 2 WEEK POST-OPERATIVE FOLLOW UP WAS PROVIDED WHICH APPEARS TO SHOW THE COVER PLATE PROTRUDING FROM THE INTERBODY. THE SAME X-RAY SHOWED THE INTERBODY AND SCREWS TO BE IN THE EXPECTED AND CORRECT POSITION WITH NO SIGNS OF SCREW LOOSENING. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AND DOING WELL. REVISION IS NOT CURRENTLY PLANNED AND HAS NOT BEEN SCHEDULED. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THIS SUBMISSION IS 1 OF 1 DEVICES INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680983 ↗
Other Intervertebral Fusion Device With Bone Graft, Cervical devices
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- ROI-C MC1005TLDR Spine Usa, Inc. · Intervertebral Fusion Device With Bone Graft, Cervical54 reports
- EIT CIF cage CUI8060LEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall1 report
- CONSTRUX - MINI PTC 37-5012SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-6211SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-7308SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-9207SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-6106SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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