CODA™ Anterior Cervical Plate System 58-102203045Recalls & reported problems
Pioneer Surgical Technology, Inc. · 3 Level Plate · 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 00840298701216), received between Dec 13, 2024 and Jan 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Fragmentation1
- Migration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO RESOLVE ON (B)(6) 2024 THAT A PATIENT WHO UNDERWENT A THREE-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY ABOUT ONE YEAR AGO REQUIRED A REVISION SURGERY. IT COULD BE SEEN ON X-RAY THAT A SCREW HAD BACKED OUT OF THE CODA PLATE. THE PATIENT WAS BROUGHT TO SURGERY ON (B)(6) 2024 TO REVISE THE SCREW. ONCE THE SURGEON HAD DISSECTED DOWN TO THE PLATE, HE SAW THAT THE LOCKING MECHANISM OF THE PLATE HAD BROKEN ON ONE SIDE AND THERE WAS A LOOSE PIECE OF METAL INSIDE THE SCREW HEAD. THE SURGEON DECIDED TO REMOVE THE LOOSE PIECE OF METAL AND THE SCREW THAT HAD BACKED OUT. HE DID NOT INSERT ANOTHER SCREW OR REPLACE THE PLATE AS THE CONTRALATERAL SIDE OF THE LOCKING MECHANISM WAS STILL INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21186115 ↗InjuryDec 13, 2024Fracture; Migration; Fracture; Migration
IT WAS REPORTED TO RESOLVE ON (B)(6) 2024 THAT THE CAUDAL SCREWS OF A THREE-LEVEL CODA PLATE WERE BACKING OUT. IT WAS ALSO SAID THAT THE PATIEN'TS SPINE WAS OUT OF ALIGNMENT FOLLOWING SURGERY. DUE TO THE SCREW BACKOUT AND THE MISALIGNMENT OF THE SPINE, A REVISION SURGERY WAS PERFORMED.
Patient problems: Insufficient Information
MAUDE report 20924539 ↗
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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