Slimplicity Plus Anterior Cervical Plating System ACP349PRecalls & reported problems
Precision Spine, Inc. · Slimplicity Plus ACP - 3 level, 49mm · Class 2 · Implant
Data updated Oct 18, 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 00840019916202), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (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 Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2020Material Twisted/Bent
INFORMATION PROVIDED INDICATES THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2020 UTILIZING THE SIMPLICITY PLUS ACDF SYSTEM. THE ANTERIOR CERVICAL PLATE PLUS 3-LEVEL 49MM (ACP349P) WAS PLACED WITH TWO SCREWS WHEN IT WAS NOTED THAT THE TIP OF ONE OF THE LOCKING RIVETS WAS BENT DOWN INTO THE SCREW HOLE. THE PLATE WAS REMOVED AND A PLATE WAS USED FROM THE BACK-UP SLIMPLICITY ACP SYSTEM SET TO SUCCESSFULLY COMPLETE THE PROCEDURE, WITH NO HARM TO THE PATIENT. THERE WAS A FIVE (5) MINUTE DELAY TO THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9764977 ↗
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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