CD HORIZON® SOLERA® Spinal System 651000065Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 651000065 5.5 CCM PERC ROD 65MM · Class 2 · Implant
All models of CD HORIZON SOLERA Spinal System (34)
Data updated Oct 18, 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 00643169748576), received between Jan 10, 2020 and Jan 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2020Break; Break
IT WAS REPORTED VIA PATIENT CALL THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT UNKNOWN SURGERY AT L4. L5 AND S1. THE IMPLANTED RODS HAD BROKEN, POST-OPERATIVELY. ON (B)(6) 2019: THE PATIENT WAS PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: I. LUMBAR RADICULOPATHY. II. LUMBAR STENOSIS. III. SP ONDYLOSIS IV. SPONDYLOLYSIS V. FORAMINAL STENOSIS AND UNDERWENT FOLLOWING PROCEDURES: I.L5-S1 ANTERIOR OBLIQUE LUMBAR INTERBODY FUSION WITH PEEK CAGE, AUTOGRAFT AND ALLOGRAFT. II. L4-L5 ANTERIOR OBLIQUE LUMBAR INTERBODY FUSION WITH PEEK CAGE, AUTOGRAFT AND ALLOGRAFT. III. POSTEROLATERAL FUSION L4-S1. AS PER OP-NOTES, ¿A 10# BLADE TWO FINGER-BREADTHS BELOW THE ASIS. THE APONEUROSIS OF THE ABDOMINAL WALL IS S IDENTIFIED AND BLUNTLY DISSECTED. WE THEN IDENTIFIED THE PERITONEUM. THIS WAS TEASED DOWN WITH BLUNT DISSECTION. WE THEN CONTINUED TO MOBILIZE THE PERITONEUM MEDIALLY. ONCE THE PERITONEUM WAS SUFFICIENTLY MOBILIZED, WE PLACED A 3 ARM RETRACTOR. THE RETRACTORS WERE PLACED. THE ANNULUS WAS INCISED. THE BONE AND DISC MATERIAL WERE THEN REMOVED POSTERIORLY IN ORDER TO ACCESS THE DISK SPACE. CURETTE AND PITUITARIES WERE USED FOR DISK SPACE. THE ALIGNMENT AT L5-S1 WAS GOOD AFTER THE TRIAL WAS PLACE
Patient problems: Pain
MAUDE report 9574799 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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