Optio-C® 07.01873.006Recalls & reported problems
Zimmer Spine, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024329591), received between Apr 18, 2022 and Nov 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN AND OPTIO-C PLATE AND PEEK IMPLANT WERE PLACED ONTO THE ASSEMBLY BLOCK DURING SURGERY ON THE BACK TABLE, THE CONNECTION BETWEEN THE TWO WAS VERY LOOSE. THEY WERE NOT IMPLANTED, INSTEAD, ANOTHER SET OF IMPLANTS WERE OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A FIVE MINUTE DELAY FOR OPENING AND PLACEMENT OF THE NEW IMPLANTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20728034 ↗MalfunctionFeb 3, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO OPTIO-C PLATES AND A PEEK IMPLANT WERE BROKEN UPON MALLET IMPACT AND HAD TO BE REPLACED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT IMPACT, BUT A MINIMAL DELAY TO REPLACE THE PLATES AND IMPLANT OCCURRED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296635 ↗MalfunctionFeb 3, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO OPTIO-C PLATES AND A PEEK IMPLANT WERE BROKEN UPON MALLET IMPACT AND HAD TO BE REPLACED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT IMPACT, BUT A MINIMAL DELAY TO REPLACE THE PLATES AND IMPLANT OCCURRED. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16296620 ↗MalfunctionApr 18, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT THE LOCKING CAP ON AN OPTIO-C PLATE "BENT OR CRACKED" UPON LOCKING; THE DOCTOR CHOSE TO LEAVE THE PLATE IMPLANTED. THERE WAS NO DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14136735 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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