CD HORIZON® Spinal System 8690853Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 8690853 M8 REDUCTION PLUG 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00721902180088), received between Dec 5, 2017 and Aug 30, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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
- Failure to Align3
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2018Failure to Align; Failure to Align
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7833088 ↗MalfunctionAug 30, 2018Failure to Align; Failure to Align
IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR THORACOLUMBAR FIXATION DUE TO LUMBAR SPONDYLOLISTHESIS. INTRA-OP THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7833077 ↗MalfunctionDec 5, 2017Failure to Align; Failure to Align
PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR DISC HERNIATION TYPE OF PROCEDURE OR TECHNIQUE USED: LUMBAR POSTERIOR FUSION SURGERY IT WAS REPORTED THAT INTRA-OP, SET SCREW SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7081930 ↗
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 13, 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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