CD HORIZON® Spinal System 55811005535Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 55811005535 5.5 SAS 5.5 X 35 CC · Class 2 · Implant
Data updated Oct 13, 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 00643169067721), received between Feb 17, 2017 and Feb 17, 2017 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2017Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY IN WHICH SCREW WAS IMPLANTED INSIDE THE PATIENT. POST-OP, ON AN UNKNOWN DATE, THE L5 SCREW BROKE RIGHT BELOW THE TULIP. THE PATIENT ALSO HAD COMPLAINTS OF BACK PAIN DUE TO NON-UNION. HENCE, ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED TO REMOVE THE SCREW. DURING THE REMOVAL OF THE SCREW, THE SLEEVE OF THE EXTRACTOR ALSO BROKE. THE SCREW WAS REMOVED AND REPLACED WITH 6.5 X 35 MM SAS SCREW. NO FRAGMENT OF THE BROKEN SCREW OR THE BROKEN EXTRACTOR REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Code Available; Pain
MAUDE report 6338488 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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