N/A 2981222Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 2981222 12X22MM 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 00885074088532), received between Jul 31, 2018 and Jul 31, 2018 — 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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L3/5 DUE TO SPINAL CANAL STENOSIS. INTRA-OP, AFTER DISSECTING THE INTERVERTEBRAL DISC AT L3/4, TRIAL WAS HAMMERED IN THE INTERVERTEBRAL DISC. AFTER IT WAS REMOVED, THE DURA WAS INJURED. THERE WAS BLEEDING AT INTERVERTEBRAL DISC FROM DECOMPRESSION. BLEEDING DID NOT STOP IMMEDIATELY. BLEEDING STOPPED FINALLY WITH USING TWO FLOSEAL, BUT THE SUTURING OF THE DURA DID NOT GO SMOOTHLY. DEVICE WAS NOT IMPLANTED AND WOUND WAS CLOSED.
Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding; Injury
MAUDE report 7734225 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 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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