CD HORIZON® Spinal System 6543650Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 6543650 6.5MM FAS FOR 5.5 50MM LG · 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 00613994197818), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2021Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTH CARE PROVIDER) REGARDING A PATIENT WITH LUMBAR 4 -5 INTERVERTEBRAL SPACE INFECTION FOR 4-5 LUMBAR DISC HERNIATION, AFTER LAMINECTOMY AND NUCLEUS PULPOSUS REMOVAL SURGERY: ANTERIOR DEBRIDEMENT BIOPSY OF LUMBAR 4-5 VERTEBRAE, SPINAL NERVE LYSIS, ILIAC BONE GRAFTING, FUSION AND INTERNAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE SCREW BROKE. THE SCREW THREAD WAS DAMAGED DURING SCREWING IN. THE PART CAME IN CONTACT WITH PATIENT. INFECTION WAS NOT CAUSED BY MEDTRONIC PRODUCTS. THE REVISION OF SURGERY WAS PERFORMED AND PART WAS EXPLANTED. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: Unspecified Infection
MAUDE report 12826203 ↗
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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