CD HORIZON® Fenestrated Screw Set 55751027550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS SAS 55751027550 STER CCM 7.5 X 50 · Class 2 · Implant
All models of CD HORIZON Fenestrated Screw Set (27)
Data updated Oct 18, 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 00763000151249), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionJan 29, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW HEAD WAS BROKEN INTRA-OPERATIVELY. THE SCREW WAS EXPLANTED. THE PATIENT SUFFERED A LUMBAR SPINE FRACTURE WITH POST-TRAUMATIC KYPHOSIS IN A TRAFFIC ACCIDENT. THE DORSAL STABILIZATION OF BWK 11/12 TO LWK 2/3 TOOK PLACE, USING MONOAXIAL SCREWS FOR THE BWK 12 AND LWK 2 SEGMENTS. SUBSEQUENTLY, A REDUCTION (RESPIRATION AND DISTRACTION) WAS CARRIED OUT USING THE SPACE T SYSTEM. UNDERNEATH, THE TULIP OF THE MONOAXIAL SCREW IN LWK 2 BENT TO THE LEFT, SO THAT THE LOCKING NUT COULD NOT BE INSERTED PROPERLY. WHEN ATTEMPTING TO BREAK OFF THE LONGHEAD BLADE, THE CLEANING SITE DID NOT BREAK OFF PROPERLY. AFTER FURTHER MANIPULATION OF THE TUBE, IT BROKE OFF. THE SCREW WAS REMOVED AND REPLACED WITH A NEW MONO AXIAL PEDICLE SCREW. THE PATIENT DID NOT SUFFER ANY HARM AS A RESULT OF THIS INCIDENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21261880 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page