CD Horizon™ Astute™ Spinal System 1608451040Recalls & reported problems
Medtronic Sofamor Danek, Inc. · PEEK ROD 1608451040 6.0 X 6.9MM STR 40MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000312947), received between Nov 1, 2022 and Apr 24, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Spinal Column Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-4 PLIF EXTEN SION SPINAL THERAPY FOR DEGENERATIVE L2-4. IT WAS REPORTED THAT DURING EXTEND CONSTRUCT, FOUND FRACTURED ASTUTE PEEK RODS. UNIDENTIFIABLE IN POST X-RAY, DISCOVERED ONLY IN INTRA-OP DURING EXTENSION. THERE WAS NO PATIENT SYMPTOM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21897463 ↗MalfunctionApr 24, 2025Fracture; Fracture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2-4 POSTERIOR LUMBAR INTERBODY FUSION(PLIF) EXTENSION SPINAL THERAPY FOR DEGENERATIVE L2-4. IT WAS REPORTED THAT DURING EXTEND CONSTRUCT, FOUND FRACTURED ASTUTE PEEK RODS. UNIDENTIFIABLE IN POST X-RAY, DISCOVERED ONLY IN INTRA-OP DURING EXTENSION. THERE WAS NO PATIENT SYMPTOM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21897440 ↗InjuryNov 1, 2022Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING RODS USED IN POSTERIOR LUMBAR FUSION THERAPY FOR ADJACENT LEVEL DEGENERATIVE DISC DISEASE. LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT THE SURGEON BECAME AWARE OF THE BREAKAGE INTRAOPERATIVELY. THE SURGEON COULD NOT DETERMINE IF THE ADJACENT LEVEL DISEASE OR COMPLICATIONS WAS FROM THE ROD BREAKAGE OR NOT. THE ROD WAS EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: Spinal Column Injury
MAUDE report 15707323 ↗
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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