CD HORIZON® Spinal System 70468580Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 70468580 CLOSED MAS 8.5X80 TI · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994158222), received between Nov 28, 2017 and Dec 31, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Most reported problems
Device problems
- Break3
Patient problems
- No Known Impact Or Consequence To Patient2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2020Break; Break
(B)(6) 2020, MPXR REPORT (B)(4), (REP, HCP,FOR): INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH TUMOR ON RIGHT SIDE IN S1 FOR OPEN PROCEDURE AT T11 - ILIUM AND S1 / L5 SPINAL THERAPY. IT WAS REPORTED THAT THE ROD AND SCREWS WAS BROKEN ON LEFT SIDE NEAR AND IN S1. THERE WAS PAIN SYMPTOMS REPORTED FOR PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 11099706 ↗MalfunctionNov 28, 2017Break; Break
IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SCOLIOSIS AND UNDERWENT AN UNSPECIFIED SURGERY. POST-OP, SCREW WAS FOUND BROKEN AT S2. THE SCREW REMAINED IN THE PATIENT. REVISION SURGERY WAS NOT SCHEDULED AS THERE WERE NO ISSUES NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7062571 ↗MalfunctionNov 28, 2017Break; Break
IT WAS REPORTED THAT PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SCOLIOSIS AND UNDERWENT AN UNSPECIFIED SURGERY. POST-OP, SCREW WAS FOUND BROKEN AT S2. THE SCREW REMAINED IN THE PATIENT. REVISION SURGERY WAS NOT SCHEDULED AS THERE WERE NO ISSUES NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7062570 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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