CD HORIZON® Spinal System 779115555Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CONNECTOR 779115555 TI AXL CL 5.5 OP 5.5 · 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
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994739353), received between Aug 10, 2017 and Dec 8, 2025 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Pain3
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THERE IS NO PLAN TO PERFORM A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739296 ↗InjuryDec 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THERE IS NO PLAN TO PERFORM A REVISION SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739123 ↗InjuryDec 7, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T10 FRACTURE-THORACIC KYPHOSIS AND UNDERWENT ARTHRODESIS AT T3-S1. POST-OP, THE CONNECTORS BROKE PREVENTING FROM FUSION. AS THE RESULT, PATIENT SUFFERED WITH PAIN. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 8144597 ↗InjuryDec 7, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH T10 FRACTURE-THORACIC KYPHOSIS AND UNDERWENT ARTHRODESIS AT T3-S1. POST-OP, THE CONNECTORS BROKE PREVENTING FROM FUSION. AS THE RESULT, PATIENT SUFFERED WITH PAIN. T3-SACRUM ARTHRODESIS, ROD REPLACEMENT, SCREW REPLACEMENT AND NUT REPLACEMENT WERE PERFORMED AS A REVISION SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 8144596 ↗MalfunctionMar 14, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, OPEN END OF THE CONNECTOR COULD NOT BREAK OFF CONNECTOR SET SCREW (KEPT STRIPPING). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7337834 ↗InjuryAug 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE ON AN UNKNOWN DATE AT LEVELS "D4-S1" .POST-OP, PATIENT HAD BACK PAIN AND HIGH KYPHOSIS DUE TO THE FACT THAT THE SET SCREW FROM CONNECTOR WAS UNSCREWED. THERE WAS NO MORE CONNECTION BETWEEN SUPERIOR AND INFERIOR CONSTRUCT WHICH WAS LINKED BY THE CONNECTOR. A REVISION SURGERY(POSTERIOR FIXATION) WAS THUS PERFORMED ON (B)(6) 2017 TO EXPLANT THE CONNECTOR AND REPLACE IT WITH DOMINO CONNECTOR.
Patient problems: No Code Available; Pain
MAUDE report 6783811 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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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