CODA™ Anterior Cervical Plate System 58-102201012Recalls & reported problems
Pioneer Surgical Technology, Inc. · 1 Level Plate · Class 2 · Implant
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 00840298700998), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Device Dislodged or Dislocated
FROM THE COMPLAINANT: IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE SURGEON REACHED OUT STATING "THE PATIENT THEY USED CODA ON CAME BACK TODAY FOR 2 MONTH POST-OP, ONE OF HER SCREWS WAS BACKING OUT." HE WAS ALMOST POSITIVE THEY CAM LOCKED. AND HE REMEMBER SEEING THE CAM SWIVEL OVER TO HAVE BOTH WINGS COVERING THE SCREWS ON BOTH LEVELS" "IF IT BACKS OUT ANYMORE, HE MAY BRING HER BACK JUST TO REVISE. MAY CONSIDER EXCHANGING THE PLATE ITSELF FOR SKYLINE, BUT HE WILL LET YOU KNOW." ADDITIONAL INFORMATION WAS RECEIVED ON 03/18/2026 THAT THE SURGEON AND PATIENT OPTED FOR A REVISION TO BE COMPLETED ON (B)(6) 2026. THE IMPACTED DEVICE WILL BE EXPLANTED AND REVISED WITH A DIFFERENT PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24638829 ↗
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- 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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