Slimplicity Anterior Cervical Plate System SDV4014Recalls & reported problems
Precision Spine, Inc. · 4.0mm x 14mm SD Variable Screw · 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 00840019905206), received between Sep 10, 2019 and Sep 10, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Appropriate Device Problem Term/Code Not Available2
- Migration or Expulsion of Device2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2019Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL IMPLANTATION ON (B)(6) 2019 UTILIZING THE SIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM. REVISION WAS PERFORMED ON (B)(6) 2019 TO ADDRESS BACK OUT OF TWO (2) 4.0MM X 14MM SD VARIABLE SCREWS (SDV4014) FROM THE C7 SEGMENT. ALL HARDWARE WAS REMOVED AND REPLACED. RADIOGRAPH PROVIDED SHOWS TWO SCREWS BACKED OUT OF THE BONE BUT NOT BACKED OUT OF THE PLATE. FOLLOWING RECEIPT OF EXPLANTED PRODUCT IT WAS IDENTIFIED THAT NONE OF THE LOCKING TABS ON THE PLATE ARE BROKEN.
Patient problems: No Information
MAUDE report 8983991 ↗InjurySep 10, 2019Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL IMPLANTATION ON (B)(6) 2019 UTILIZING THE SIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM. REVISION WAS PERFORMED ON (B)(6) 2019 TO ADDRESS BACK OUT OF TWO (2) 4.0MM X 14MM SD VARIABLE SCREWS (SDV4014) FROM THE C7 SEGMENT. ALL HARDWARE WAS REMOVED AND REPLACED. RADIOGRAPH PROVIDED SHOWS TWO SCREWS BACKED OUT OF THE BONE BUT NOT BACKED OUT OF THE PLATE. FOLLOWING RECEIPT OF EXPLANTED PRODUCT IT WAS IDENTIFIED THAT NONE OF THE LOCKING TABS ON THE PLATE ARE BROKEN.
Patient problems: No Information
MAUDE report 8983978 ↗
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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