Hyper-C Anterior Cervical Plate System 0201-4016VRecalls & reported problems
Degen Medical, Inc. · Bone Screw, Self Drilling, 4.0 X 16 Variable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842048106197), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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
- Material Protrusion/Extrusion1
- Unintended Movement1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2020Material Protrusion/Extrusion; Unintended Movement; Material Protrusion/Extrusion; Unintended Movement
DEGEN MEDICAL WAS NOTIFIED THAT A HYPER-C ANTERIOR CERVICAL SYSTEM SCREW BACKED OUT OF A 4-LEVEL CYCLOPS ANTERIOR CERVICAL SYSTEM PLATE. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2020. RADIOGRAPHIC IMAGES DURING A POST-OPERATION FOLLOW-UP WITH THE PATIENT SHOWED THAT ONE CERVICAL SCREW BACKED OUT FROM THE PLATE. A REVISION SURGERY WAS COMPLETED ON (B)(6) 2020 TO REMOVE THE EXISTING PLATE AND SCREWS AND TO IMPLANT A NEW CERVICAL PLATE AND SCREWS. DURING THE REMOVAL OF THE ORIGINAL HARDWARE AS PART OF THE REVISION SURGERY IT WAS FOUND THAT THE LOCKING MECHANISM, WHICH WAS INTENDED TO COVER THE BACKED OUT SCREW, WAS IN THE OPEN POSITION. THE LOCKING MECHANISM HAD BROKEN AWAY FROM THE PLATE. NO PATIENT HARM WAS REPORTED FROM THIS EVENT. THIS REPORT CAPTURES THE SCREW. AN ADDITIONAL REPORT IS CREATED FOR THE PLATE.
Patient problems: Failure of Implant
MAUDE report 10836227 ↗
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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