Hive Standalone Cervical System 08-A-2001-4007Recalls & reported problems
Nanohive Medical LLC · 15Wx12Lx7H, 6° Zero Profile - 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 00817493024792), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Implant subsidence” (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
- Implant subsidence1
- Migration1
Patient problems
- Inadequate Osseointegration1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2025Migration; Implant subsidence; Migration; Implant subsidence
THIRD PARTY AGENT REPORTED TO NANOHIVE OF A REVISION SURGERY DUE TO A CAGE THAT HAD MIGRATED POSTERIORLY. IMPLANTATION SURGERY OCCURRED ON (B)(6) 2024 AND WAS A TWO LEVEL ANTERIOR CERVICAL DISCECTOMY FUSION PROCEDURE AT C4/5 AND C5/6. DURING A ROUTINE FOLLOW UP ON (B)(6) 2024 , RADIOGRAPHIC IMAGING NOTED A SUBSIDENCE AND MIGRATION OF THE PATIENT'S C5/C6 INTERBODY AND SCREW. THE PATIENT REPORTED NO TRAUMA OR PAIN. REVISION SURGERY USING A PLATE AND CAGE OCCURRED ON (B)(6) 2024 . THE PATIENT WAS REPORTED TO BE RECOVERING WELL WITH NO ADDITIONAL CONCERNS.
Patient problems: Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture
MAUDE report 21096641 ↗
Other Intervertebral Fusion Device With Bone Graft, Cervical devices
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- EIT CIF cage CUI8070SEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall4 reports
- EIT CIF cage CUI8060LEIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Cervical1 recall1 report
- CONSTRUX - MINI Ti 37-7212SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8015SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-7206SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- CONSTRUX - MINI Ti 37-8007SPOrthofix US LLC · Intervertebral fusion device with bone graft, cervical1 recall0 reports
- 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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