ELEVATE™ Spinal System NAV2134Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSERTER NAV2134 DRIVE SHAFT · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000141424), received between Feb 1, 2022 and Jan 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT INSERTERS WERE BROKEN AS HANDLES BROKE ON BOTH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960365 ↗MalfunctionDec 26, 2023Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/S1 POSTERIOR FUSION AND TLIF FOR L5/S1 DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE TORQUE HANDLE RELEASED WHEN REACHED MAXIMUM TORQUE DUE TO THIS THE TIP OF THE INSERTER SHEARD OFF INSIDE THE IMPLANT IN THE PATIENT. STEPS WERE TAKEN TO REMOVE THE SHEARED COMPONENT. THE SURGEON THEN USED A PENCIL TIP HIGH SPEED DRILL TO SECTION AND REMOVE THE RETAINED TIP IN PIECES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18391331 ↗MalfunctionFeb 1, 2022Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF DUE TO UNK NOWN INDICATION. IT WAS REPORTED THAT WHEN EXPANDING THE IMPLANT THE TIP OF THE TORQUE-LIMITING INNER DRIVER SHAFT SHEARED OFF INTO THE IMPLANT. TIP IS LODGED INTO THE IMPLANT AND WOULDN'T COME OUT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 13411870 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.