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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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