CODA™ Anterior Cervical Plate System 58-102250016Recalls & reported problems
Pioneer Surgical Technology, Inc. · Variable Self Drilling 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 00840298702428), received between Nov 15, 2024 and Feb 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Migration2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2025Fracture; Migration; Fracture; Migration
IT WAS REPORTED TO RESOLVE THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE SCREWS IN THE INFERIOR LEVEL OF A THREE-LEVEL CODA PLATE WERE FRACTURED AND BACKING OUT. IT WAS SAID IN THE REPORT THAT THE PATIENT REQUIRED A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 21346977 ↗InjuryNov 15, 2024Fracture; Migration; Fracture; Migration
ON (B)(6) 2024, DR. (B)(6), PERFORMED A C3-6 ACDF USING PROTI ACIS AND A CODA PLATE. IT WAS REPORTED TO PIONEER ON (B)(6) 2024 THAT THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY TO HAPPEN ON (B)(6) 2024 TO EXTEND THE CONSTRUCT DOWN TO C7. PREOPERATIVE X-RAYS FOR THE EXTENSION SURGERY SHOWED THAT THE CODA SCREWS IN THE C6 BODY APPEARED TO BE BROKEN AND WERE BACKING OUT OF THE PLATE. A REVISION SURGERY THEN OCCURRED. PATIENT OUTCOME IS UNKNOWN FOLLOWING REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 20694248 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page