N/A 2561132Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 2561132 LOOP 11MM X 32.5MM 6DEG · Class 2 · Implant
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 00643169241923), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT PATIENT WITH HERNIATED DISC AT L4-5 UNDERWENT DISCECTOMY AND ADDITIONAL FIXATION USING AN INTERSPINOUS FIXATION DEVICE.POST-OP, PATIENT FELT ACUTE PAIN AND RETURNED TO THE HOSPITAL. AFTER "TAC" SCAN THE SURGEON FOUND THAT THE IMPLANT WAS DISPLACED AND WAS COMPRESSING THE L4-L5 NERVE ROOT. ADDITIONAL SURGERY WAS PERFORMED TO RE-POSITION THE IMPLANT. DURING THE REVISION SURGERY A DISCECTOMY AT L5-S1 WAS PERFORMED AND PEDICLE SCREWS AT L4-L5-S1 WERE IMPLANTED.
Patient problems: No Code Available; Pain
MAUDE report 6412302 ↗
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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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