Optio-C® 07.01858.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024329393), received between Jan 26, 2026 and Jan 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TWO 7MM OPTIO-C PEEK CAGES DID NOT ASSEMBLE CORRECTLY TO THEIR MATING PLATES INTRA-OPERATIVELY. THE CONNECTION WAS TOO LOOSE AND THEY WOULD NOT STAY ATTACHED TOGETHER. THE ATTEMPTED ASSEMBLY WAS PERFORMED AT THE BACK TABLE AND THEY WERE REPLACED WITH ADDITIONAL IMPLANTS TO COMPLETE THE PROCEDURE WITHOUT ANY IMPACTS TO THE PATIENT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180193 ↗
• MalfunctionJan 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TWO 7MM OPTIO-C PEEK CAGES DID NOT ASSEMBLE CORRECTLY TO THEIR MATING PLATES INTRA-OPERATIVELY. THE CONNECTION WAS TOO LOOSE AND THEY WOULD NOT STAY ATTACHED TOGETHER. THE ATTEMPTED ASSEMBLY WAS PERFORMED AT THE BACK TABLE AND THEY WERE REPLACED WITH ADDITIONAL IMPLANTS TO COMPLETE THE PROCEDURE WITHOUT ANY IMPACTS TO THE PATIENT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179936 ↗