CD HORIZON® Fenestrated Screw Set 55750027550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · FNS MAS 55750027550 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 00763000149185), received between Jun 16, 2026 and Jun 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (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
- Mechanics Altered1
Patient problems
- Extravasation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FIXAT ION PROCEDURE AT L1¿L3. THE PROCEDURE WAS PERFORMED AS A REVISION SURGERY FOLLOWING A PRIOR BKP AT L2 FOR OSTEOPOROTIC COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, A GAP BETWEEN THE LOCKING OUTER SLEEVE AND THE TAB EXTENDER CAP WAS NOTICED. THE PHYSICIAN WAS CONSULTED AND INDICATED THAT IT SHOULD BE FINE AS THE BUTTON COULD NOT BE PRESSED. HOWEVER, CEMENT LEAKAGE WAS CONFIRMED UNDER IMAGING. THE SCREW WAS REMOVED AND INSERTED AGAIN TO ADDRESS THE ISSUE. PRIOR REVISION SURGERY WAS PERFORMED FOR INSTABILITY OF THE ADJACENT VERTEBRAL BODIES, DESCRIBED AS ADJACENT SEGMENT DISEASE, AND NOT DUE TO A CEMENT PRODUCT ISSUE. IT WAS ALSO CONFIRMED THAT NO ISSUE WAS IDENTIFIED WITH THE CEMENT ITSELF AND THAT THE REPORTED CEMENT LEAKAGE DURING THE CURRENT PROCEDURE WAS ATTRIBUTED TO THE FENESTRATED SCREW ISSUE, SPECIFICALLY THE GAP BETWEEN THE LOCKING OUTER SLEEVE AND TAB EXTENDER CAP. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Extravasation
MAUDE report 25516228 ↗
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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