Hive Standalone Cervical System 08-A-0101-4007Recalls & reported problems
Nanohive Medical LLC · 15Wx12Lx7H, 6° Plated - Tube Package Configuration · Class 2 · Implant
Data updated Oct 18, 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 00817493025072), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 2/3/2025, THIRD PARTY AGENT REQUESTED FROM NANOHIVE AN IMPLANT REMOVAL SET FOR A CERVICAL STANDALONE PLATED IMPLANT. INITIAL IMPLANTATION SURGERY OCCURRED ON (B)(6) 2024 AND WAS A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE. THE THIRD-PARTY AGENT WAS PRESENT AT THIS SURGERY AND IT REPORTEDLY WENT WELL. APPROXIMATELY 5 MONTHS POST-SURGERY, THE PATIENT REPORTED PAIN BUT SUBSEQUENT MRI RESULTS REPORTEDLY SHOWED NO ISSUES. THE PATIENT WENT TO ANOTHER SURGEON AND REVISION SURGERY OCCURRED ON (B)(6) 2025. THE AGENT HELPED FACILITATE THE INSTRUMENTS FOR REMOVAL. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 21756639 ↗
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- CONSTRUX - MINI Ti 37-7212SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
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- CONSTRUX - MINI Ti 37-7206SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
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- CONSTRUX - MINI PTC 37-4211SPOrthofix 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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