NexGen Anterior Cervical Plate System 65-DF-4016Recalls & reported problems
Precision Spine, Inc. · Self-Drilling Fixed Screw - 4.0mm x 16mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840019932790), received between Jan 14, 2026 and Jan 14, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration2
- Migration or Expulsion of Device2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Migration or Expulsion of Device; Migration
IT WAS REPORTED THAT THE PATIENT INDERWENT A PROCEDURE ON (B)(6) 2024 UTILIZING THE SLIMPLICITY HP ANTERIOR CERVICAL PLATE SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS SCREW BACKOUT. THE TWO 4.0MM X 16MM SELF DRILLING FIXED SCREW SLIMPLICITY HP (65-DF-4016) LOCATED AT THE BOTTOM OF THE PLATE HAVE STARTED TO BACK OUT. IT WAS ALSO NOTED UPON GOING IN, THAT THE BOTTOM LOCKING MECHANISM ON THE PLATE ASSEMBLY 2-LEVEL 30MM SLIMPLICITY HP (65-CA-2030) WAS BROKEN/UNATTACHED.
Patient problems: Failure of Implant
MAUDE report 24073077 ↗InjuryJan 14, 2026Migration or Expulsion of Device; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024 UTILIZING THE SLIMPLICITY HP ANTERIOR CERVICAL PLATE SYSTEM. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS SCREW BACKOUT. THE TWO 4.0MM X 16MM SELF DRILLING FIXED SCREW SLIMPLICITY HP (65-DF-4016) LOCATED AT THE BOTTOM OF THE PLATE HAVE STARTED TO BACK OUT. IT WAS ALSO NOTED UPON GOING IN, THAT THE BOTTOM LOCKING MECHANISM ON THE PLATE ASSEMBLY 2-LEVEL 30MM SLIMPLICITY HP (65-CA-2030) WAS BROKEN/UNATTACHED.
Patient problems: Failure of Implant
MAUDE report 24073075 ↗
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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