N/A 2982040Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TRIAL 2982040 10 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 00885074549750), received between Jun 20, 2020 and Jun 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Use of Device Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2020Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPINAL CANAL STENOSIS; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L2-L5. BEFORE TRIAL INSERTION, THE DISTRACTOR HAD BEEN SET TO 12 MM, AND THE TRIAL WAS STARTED FROM HEIGHT OF 10 MM. INTRA-OP, WHILE ATTEMPTING TO INSERT THE TRIAL AT L4-L5 AT THE FIRST LEVEL, THE TRIAL PROTRUDED ABOUT 20 MM FROM THE CONTRALATERAL SIDE AS A RESULT OF STRONG HAMMERING. THE DIRECTION REMAINED DIAGONAL BEFORE RAISING VERTICALLY. STRONG HAMMERING WAS PERFORMED AS THE ENTRANCE OF THE INTERVERTEBRAL DISC SPACE WAS NARROW. AS A RESULT OF TRIAL PROTRUSION INTO THE VERTEBRAL BODY, THE PATIENT HAD A LOT OF BLEEDING (AMOUNT UNKNOWN) AND HEMOSTASIS WAS PERFORMED. THEN, THE WOUND WAS CLOSED WITHOUT INSERTING THE CAGE. ORIGINALLY, IT WAS PLANNED TO PERFORM A SECOND STAGE FIXATION BUT IT COULD NOT BE PERFORMED THEN. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE AS A RESULT OF THIS EVENT. THE SURGEON FEELS THAT IT MAY HAVE BEEN NECESSARY TO START THE TRIAL FROM A SMALLER SIZE. ALTHOUGH THE EXACT PLACE OF BLEEDING WAS UNKNOWN, THE SURGEON SUSPECTED THE BLEEDING TO BE FROM VENOUS PLEXUS NEAR THE CONTRALATERAL ROUTE. THE SURGEON ALSO BELIEVES
Patient problems: Blood Loss
MAUDE report 10177132 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page