Optio-C® 07.01859.006Recalls & reported problems
Zimmer Spine, Inc. · Class 2
Data updated Oct 16, 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 00889024329454), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
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 TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20727933 ↗
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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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