n/a 7080911Recalls & reported problems
Medtronic Sofamor Danek, Inc. · AWL 7080911 FIXED ANGLE AWL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000884574), received between Sep 14, 2025 and Sep 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2025Material Deformation; Material Deformation
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS STRIPPED AND BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE HAS STRIPPED ONLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23047905 ↗
Other AWL devices
- Meridian RA2-003015Seaspine Orthopedics Corporation · AWL1 recall1 report
- AMP 117-165Alphatec Spine, Inc. · AWL1 recall0 reports
- SYNFIX Evolution 03.835.032Synthes GmbH · AWL16 reports
- NA 359.213Synthes GmbH · AWL7 reports
- NA 03.010.041Synthes GmbH · AWL7 reports
- ENDOSKELETON® TAS 2300-1110Medtronic Sofamor Danek, Inc. · AWL7 reports
- NA 03.820.100Synthes GmbH · AWL6 reports
- Endoskeleton™ TCS Interbody System 5210-1063Medtronic Sofamor Danek, Inc. · Awl5 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.
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