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NanoHive IBFD 03-A-0006-4010Recalls & reported problems

Nanohive Medical LLC · TLIF, 10W, 30L, 10H, 10° · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817493020824), received between Oct 28, 2019 and Oct 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Device problems

  • Fracture1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2019Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

    IT WAS REPORTED THAT THE DEVICE BROKE INTO TWO PIECES DURING AN ATTEMPT TO ROTATE THE DEVICE INTO POSITION IN THE DISC SPACE. THE PROXIMAL PIECE OF THE DEVICE WAS COMPLETELY REMOVED. THE DISTAL PIECE OF THE DEVICE WAS REPORTED TO BE IN THE DESIRED POSITION IN THE DISC SPACE AND WAS LEFT IN THE PATIENT AT THE SURGEON'S DISCRETION. RESULTED IN NO DELAY IN SURGERY AND NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9247999 ↗

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Sources and updates

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