CD HORIZON® Spinal System 8115516Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CROSSLINK 8115516 16MM X10 FIXED · 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
- 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 00721902729355), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Disintegration” (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 16, 2026.
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2018Material Disintegration; Material Disintegration
PRE-OPERATIVE DIAGNOSIS: PATIENT RESUMED FOR DEFINITIVE ARTHRODESIS, PRESENCE OF METALLOSIS AT THE LEVEL OF THE CROSSLINK PROCEDURE: DISMANTLING OF THE CROSSLINK AND CLEANING OF THE METALLOSES AND BACTERIOLOGICAL AND PATHOLOGICAL SAMPLES IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY ON AN UNKNOWN DATE. POST-OP, THE CROSSLINK WAS FOUND DISASSEMBLED IN SITU ON THE RIGHT SIDE OF THE PATIENT SUCH THAT THE RIGHT SCREW GOT DETACHED FROM THE CROSSLINK. SURGICAL RESUMPTION FOR DEFINITIVE ARTHRODESIS WAS PERFORMED AS A RESULT OF THE EVENT. THE DEVICE DID NOT BREAK. PATIENT COMPLICATION WERE REPORTED AS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7817780 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
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- 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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