Optio-C® 07.01873.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024329607), received between Aug 3, 2020 and Jan 26, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179971 ↗
• MalfunctionAug 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED THE OPTIO-C DEVICE BY IMPACTING IT IN ORDER TO GET THE IMPLANT SEATED, AND AS THE SURGEON WAS IN THE PROCESS OF FINAL TIGHTENING, THE LOCKING PLATE BROKE. THE SURGEON REMOVED THE IMPLANT AND USED A DIFFERENT ONE TO COMPLETE THE CASE. THERE WAS A 10-MINUTE DELAY WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637465 ↗
• MalfunctionAug 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PLATE DISASSEMBLED. IT WAS REMOVED AND REPLACED WITH A SAME SIZED PLATE TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359869 ↗