CD HORIZON® Spinal System 96509HTRecalls & reported problems
Medtronic Sofamor Danek, Inc. · CONNECTOR 96509HT AXIAL 6.35- 6.35TI · Class 2 · Implant
Data updated Oct 13, 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 00673978096810), received between May 26, 2020 and May 26, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY DUE TO IDIOPATHIC SCOLIOSIS. POST-OP, PATIENT WAS MENTALLY UNSTABLE. SHE WAS IN A TREATMENT FACILITY AND WANTED TO GET OUT, THEREFORE SHE THREW HERSELF AGAINST A WALL, BREAKING HER SPINAL HARDWARE (BROKEN ROD CONNECTOR). SO SHE UNDERWENT REVISION SURGERY ON (B)(6) 2020, IN WHICH THE IMPLANT AND SURROUNDING HARDWARE WERE REMOVED. THERE WERE NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10085845 ↗
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- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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