N/A 2982840Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TRIAL 2982840 8 X 40MM L DISTRACTOR · Class 2
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 00885074549873), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2018Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION AT L1/2 DUE TO LUMBAR CANAL STENOSIS. INTRA-OP, WHEN OPERATING WITH THE TRIAL, IT GOT IN THROUGH THE FACET JOINT, THERE WAS A HIGH POSSIBILITY OF CONTACTING THE SPINAL CORD (INFERRED BY THE IMAGE OF FRONTAL AND SAGITTAL). THE TRIAL WAS REINSTALLED IN THE CORRECT POSITION AND THE MRI WAS TAKEN AFTER SURGERY. WHEN TAKING THE MRI, IT WAS FOUND THAT A BONE FRAGMENT CAME IN CONTACT WITH THE SPINAL CANAL AND SPINAL STENOSIS HAD OCCURRED, SO A POSTERIOR LAMINECTOMY WAS PERFORMED AND THE BONE FRAGMENT WAS REMOVED. THERE WAS NO INJURY TO THE DURA. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. POST-OPERATIVE PATIENT STATUS WAS UNKNOWN.
Patient problems: Stenosis
MAUDE report 7323644 ↗
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- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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