CD HORIZON® Spinal System 859-645Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 859-645 5.5 FIXED ANGLE 6.5X45 TI · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00673978063522), received between Nov 15, 2016 and Oct 4, 2017 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Device Inoperable1
- Failure to Align1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2017Device Inoperable; Device Inoperable
PROCEDURE: POSTERIOR REDUCTION AND INTERNAL FIXATION AND SPINAL DECOMPRESSION IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY DUE TO L3 VERTEBRAL BURST FRACTURES. DURING SURGERY, HEAD OF THE IMPLANTED SCREW WAS DAMAGED. THE THREADS WERE DAMAGED AND SO THE SCREW WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6914480 ↗MalfunctionJul 28, 2017Break; Break
IT WAS REPORTED THAT PATIENT WITH PRE OPERATIVE DIAGNOSIS OF "WAIST 4,5 DISC PROLAPSE, WITH 1 DEGREE SLIPPAGE" UNDERWENT LUMBAR POSTERIOR OPEN FUSION. INTRA-OP, THE SCREW BROKE. NO FRAGMENT OF THE BROKEN SCREW REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6749714 ↗MalfunctionNov 15, 2016Failure to Align; Failure to Align
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE DOCTOR FOUND THAT THE PRODUCT SLIPPED. DOCTOR REPLACED THE SLIPPED PRODUCT WITH A NEW ONE TO COMPLETE THE SURGERY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6101331 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
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- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.