N/A 2982240Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TRIAL 2982240 DISTRACTOR 12X40MM · 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 00885074549804), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Injury1
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2020Use of Device Problem; Use of Device Problem
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
Patient problems: Injury; Nerve Damage
MAUDE report 9688884 ↗
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- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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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