Skip to content

InterFuse S 9076-12-20-5Recalls & reported problems

Next Orthosurgical, Inc. · Intervertebral Body Fusion Device · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00819475010113), received between Nov 14, 2016 and May 10, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device3

Patient problems

  • No Information3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    THE PATIENT PRESENTED AT APPROXIMATELY ONE MONTH POST-OP WITH PAIN. IMAGING REVEALED FUSION CONSTRUCT FAILURE, BOTH SCREWS (SCREWS NOT PROVIDED BY VTI) AND INTERBODY. THE DOCTOR STATED THE PATIENT WAS HIGH RISK (HIGH BMI AND OSTEOPENIC BONE). SCREWS AND INTERBODY WERE REVISED. A REVIEW OF THE IMAGES SHOWED THE SECOND B MODULE IS NO LONGER LOCKED TO THE FIRST B MODULE AND HAS MIGRATED, WITH ATTACHED C MODULE, ABOUT 10MM POSTERIORLY. IN ADDITION, THE DEVICE IS ROTATED SLIGHTLY IN THE DISC SPACE.

    Patient problems: No Information

    MAUDE report 6558966 ↗
  • InjuryNov 14, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

    THE SURGEON, THROUGH THE DISTRIBUTOR, REPORTED THE C MODULE DISENGAGED AT L4-L5. REOPERATION WAS CONDUCTED TO REMOVE THE C MODULE. THE REMAINING MODULES WERE LEFT IN THE DISC SPACE, AS BONY STRUCTURES WERE APPARENT IN THE A AND B MODULES.

    Patient problems: No Information

    MAUDE report 6099793 ↗
  • InjuryNov 14, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

    THE SURGEON, THROUGH THE DISTRIBUTOR, REPORTED THE C MODULE DISENGAGED. REOPERATION WAS CONDUCTED TO REMOVE THE C MODULE. THE REMAINING MODULES WERE LEFT IN THE DISC SPACE.

    Patient problems: No Information

    MAUDE report 6099789 ↗

Other Intervertebral Fusion Device With Bone Graft, Lumbar devices

All Intervertebral Fusion Device With Bone Graft, Lumbar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.