Optio-C® 07.01875.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024329713), received between Apr 28, 2023 and Apr 28, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833901 ↗
• MalfunctionApr 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833746 ↗
• MalfunctionApr 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833698 ↗
• MalfunctionApr 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED FOUR SCREWS LABELED AS OPTIO-C SELF-DRILLING VARIABLE SCREWS, BUT THEY ARE NOT OPTIO-C SCREWS; THEY APPEAR TO BE TRINICA STANDARD/SELECT SELF-DRILLING VARIABLE SCREWS. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833681 ↗