N/A 2981022Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 2981022 10X22MM DSTRCTR TRIAL · 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 00885074088495), received between Nov 21, 2017 and Nov 21, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRE-OPERATIVE DIAGNOSIS :L3-L5: LUMBAR CANAL STENOSIS, ANTERIOR SPONDYLOLISTHESIS WITH L41 DEGREES; PROCEDURE: L2-L3: LAMINOPLASTY, L3-L5: INTERBODY FUSION IT WAS REPORTED THAT DURING SURGERY, THE DURA MATER WAS INVOLVED WHEN THE TRIAL WAS PULLED OUT. AS A RESULT, THE CAUDA EQUINE NERVE WAS EXPOSED AND BLEEDING STARTED WHICH COULD NOT BE STOPPED AND EXCEEDED 2500 CC. SURGICAL SITE WAS NOT VISIBLE DUE TO BLEEDING. NO PRODUCT MALFUNCTION WAS REPORTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT.
Patient problems: Blood Loss; Injury
MAUDE report 7047778 ↗
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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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