CD HORIZON® Spinal System 7226550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CDH LEGACY PEEK 7226550 MAS 6.5x50mm · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074362915), received between Mar 10, 2017 and Oct 1, 2019 — classified as 5 injuries.
The most frequently reported specific device problem is “Break” (5 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.
Most reported problems
Device problems
- Break5
Patient problems
- No Known Impact Or Consequence To Patient4
- No Code Available1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2019Break; Break
DURING THE REVISION SURGERY, REMOVAL OF PREVIOUS INSTRUMENTATION AND RE-FUSION WAS PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139613 ↗InjuryOct 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2016, THE PATIENT UNDERWENT L4-L5 STABILIZATION AND L5-S1 FUSION DECOMPRESSION, IN WHICH THE RODS AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE REPORTED SCREW BROKE. THE PATIENT ALSO SUFFERED FROM ADJACENT LEVEL DEGENERATION. HENCE, ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO INJURY TO THE PATIENT HAS BEEN REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139610 ↗InjuryOct 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2016, THE PATIENT UNDERWENT L4-L5 STABILIZATION AND L5-S1 FUSION DECOMPRESSION, IN WHICH THE RODS AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE REPORTED SCREW BROKE. THE PATIENT ALSO SUFFERED FROM ADJACENT LEVEL DEGENERATION. HENCE, ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO INJURY TO THE PATIENT HAS BEEN REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139566 ↗InjuryOct 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2016, THE PATIENT UNDERWENT L4-L5 STABILIZATION AND L5-S1 FUSION DECOMPRESSION, IN WHICH THE RODS AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE REPORTED SCREW BROKE. THE PATIENT ALSO SUFFERED FROM ADJACENT LEVEL DEGENERATION. HENCE, ON 03-SEP-2019, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO INJURY TO THE PATIENT HAS BEEN REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139563 ↗InjuryMar 10, 2017Break; Break
PRE-OPERATIVE DIAGNOSIS: L4-5 INSTABILITY DUE AUTOMOBILE ACCIDENT PROCEDURE: REVISION LUMBAR FUSION LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT MET WITH AN AUTOMOBILE ACCIDENT. AS A RESULT OF THIS, THE IMPLANTED SCREWS WERE BROKEN AND THE PATIENT SUFFERED WITH BACK PAIN. THE PATIENT HAD UNDERGONE REVISION SURGERY ON FOR REMOVAL OF BROKEN SCREWS AND REPLACEMENT OF THESE SCREWS WITH 'HA' SCREWS SUPPLEMENTED WITH BONE CEMENT.
Patient problems: No Code Available; Pain
MAUDE report 6394386 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease 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.
How reports and recalls are matched · Editorial policy · Report an error on this page