ZEPHIR® Anterior Cervical System 8792113Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 8792113 ZEPHIR VAST 3.5X13 · Class 2 · Implant
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 00673978955261), received between Dec 20, 2019 and Dec 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Most reported problems
Device problems
- Break2
- Loosening of Implant Not Related to Bone-Ingrowth2
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.
MalfunctionDec 20, 2019Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED AS PER A LITIGATION COMPLAINT THAT ON AN UNKNOWN DATE IN 2013, THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL INJURY CAUSED FROM AN ACCIDENT IN THE SCHOOL. ALLEGEDLY, A CERVICAL VERTEBRA WAS SURGICALLY IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE IMPLANT WAS FOUND BROKEN AND LOOSENED. NO MORE INFORMATION IS AVAILABLE NOW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9500931 ↗MalfunctionDec 20, 2019Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED AS PER A LITIGATION COMPLAINT THAT ON AN UNKNOWN DATE IN 2013, THE PATIENT UNDERWENT A SURGERY DUE TO CERVICAL INJURY CAUSED FROM AN ACCIDENT IN THE SCHOOL. ALLEGEDLY, A CERVICAL VERTEBRA WAS SURGICALLY IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE IMPLANT WAS FOUND BROKEN AND LOOSENED. NO MORE INFORMATION IS AVAILABLE NOW.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9500893 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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