CD HORIZON® Spinal System 5135251Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DOMINO 5135251 VARIABLE ANGLE 5.5/6.0 · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 16, 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 00643169754638), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6)) L5-S1 INTERBODY FUSION PROCEDURE IN A PATIENT (PATIENT ID: (B)(6)). PATIENT MEDICAL HISTORY: CHOLESTEROL, HIGH BLOOD PRESSURE, THROAT CANCER AND GERD INTERVENTIONS: PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 TO (B)(6) 2025 FOR REVISION SURGERY FROM T3 TO PELVIS LEVELS IT WAS REPORTED THAT THE PATIENT HAD: 1: EXPLORATION OF SPINAL FUSION, 2: REVISION POSTERIOR LATERAL SPINAL FUSION T3-S1, 3: T10-L3 POSTERIOR COLUMN OSTEOTOMY, 4: REINSERTION OF SPINAL FIXATION DEVICE (LUMBAR SCREWS), 5: POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION T3- ILIUM, 6: PLACEMENT OF AUTOGRAFT AND ALLOGRAFT FOR SPINAL ARTHRODESIS, 7: T12-L1 INTERBODY FUSION, 8: PLACEMENT OF BIOMECHANICAL DEVICE (TLIF CAGE), 9: OPEN BILATERAL SACROILIAC JOINT ARTHRODESIS AND 10: INTERSPINOUS TETHERING FOR PJF/PJK PROPHYLAXIS. THE AE IS DETERMINED TO BE RESOLVED SUBJECT WAS STABILIZED, RECOVERED, AND DISCHARGED FROM THE HOSPITAL. NO PRODUCT MALFUNCTION. AS PER SITE ASSESSMENT, EVENT IS POSSIBLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. SPONSOR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604071 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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