CD HORIZON® Spinal System X0212513Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCR X0212513 SOL 5.5-6.0 UAS CC 5.5X35 · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169606951), received between Jun 7, 2019 and Jun 7, 2019 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS CORRECTION SURGERY AT T3-L3. THE PATIENT HAD A STIFF DOUBLE MAJOR SCOLIOTIC CURVE. INTRA-OP, WHEN SURGEON APPLIED FORCE TO THE SEGMENTAL DEROTATORS, THE SCREW HEAD GOT DEFORMED IN THE CORONAL PLANE; WHICH ULTIMATELY PLOWED THROUGH THE LATERAL VERTEBRAL WALL OF LEFT SIDE L2 (AWAY FROM THE SPINAL CORD). THE SCREW WAS THEN COMPLETELY EXPLANTED. THIS LEVEL WAS LEFT UN-INSTRUMENTED AFTER THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8678017 ↗MalfunctionJun 7, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOSIS CORRECTION SURGERY AT T3-L3. INTRA-OP, WHEN SURGEON APPLIED FORCE TO THE SEGMENTAL DEROTATORS, THE SCREW HEAD GOT DEFORMED IN THE CORONAL PLANE; WHICH ULTIMATELY PLOWED THROUGH THE LATERAL VERTEBRAL WALL OF LEFT SIDE L1 (AWAY FROM THE SPINAL CORD). THE SCREW WAS THEN COMPLETELY EXPLANTED. THIS LEVEL WAS LEFT UN-INSTRUMENTED AFTER THE EVENT. THE PATIENT HAD A STIFF DOUBLE MAJOR SCOLIOTIC CURVE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8677999 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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