N/A 8350292Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PROBE 8350292 STRAIGHT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994282682), received between Sep 14, 2022 and Sep 14, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2022Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR ARTHRODESIS THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15415638 ↗MalfunctionSep 14, 2022Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR ARTHRODESIS THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15415556 ↗
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- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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