N/A 8880021Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 8880021 SILO AWL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074237176), received between Aug 2, 2021 and Aug 2, 2021 — classified as 1 death.
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
- Exsanguination1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH DEGENERATIVE SCOLIOSIS FOR T10-IL, L5 / S1 PLIF SPINAL THERAPY. IT WAS REPORTED THAT THE CAUSE FOR DEATH HAS NOT BEEN DETERMINED, BUT IT WAS SUSPECTED TO BE DUE TO MASSIVE BLEEDING CAUSED BY SEGMENTAL ARTERIOVENOUS INJURY. A POSSIBLE CAUSE OF DAMAGE WAS THAT THE INSTRUMENT SLIPPED FROM THE INSERTION POINT DURING THE OPERATION OF MAKING SCREW PILOT HOLE WITH OAR OR PROBE, MAKING SEGMENTAL ARTERIOVENOUS INJURED. THE DAY AFTER THE SURGERY, THE CONDITION DETERIORATED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR LAPAROTOMY. ON THE DAY OF THE OPERATION, SCREWING WAS PERFORMED AFTER DEPLOYMENT , BUT THE PATIENT'S PEDICLE DIAMETER WAS VERY SMALL, AND IT WAS VERY DIFFICULT TO MAKE A PILOT HOLE AT THE THORACOLUMBAR SPINE JUNCTION. AT THAT TIME, THE OAR OR PROBE MAY HAVE SLIPPED OFF THE INSERTION POINT AND DAMAGED THE SEGMENTAL ARTERIES AND VEINS. DURING THE OPERATION, THE VITAL SEEMED TO BE UNSTABLE, AND THE OPERATION HAD BEEN PROCEEDED WHILE THE ANESTHESIOLOGIST WAS ADMINISTERING VARIOUS MEDICINES TO STABILIZE THE VITAL, AND THE SURGEON ALSO STOPPED MEDICINES ADMINIST
Patient problems: Exsanguination
MAUDE report 12257907 ↗
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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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