DS Implants 68015205Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532261442), received between Sep 10, 2024 and Jun 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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.

• MalfunctionJun 22, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL ISSUE. IT DID NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577118 ↗
• MalfunctionFeb 24, 2026Mechanical Problem

  CUSTOMER REPORTED A TOOL MALFUNCTION: SCREWDRIVER TIP TWISTED, STUCK IN RATCHET INSERT, TOOL WAS IN USE APPROX. 1 YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436898 ↗
• MalfunctionFeb 24, 2026Mechanical Problem

  CUSTOMER REPORTED A TOOL MALFUNCTION: SCREWDRIVER TIP TWISTED, MATERIAL DEFECT BOTH TOOLS WERE IN USE FOR APPROXIMATELY 2 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436868 ↗
• InjurySep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  HEX DRIVER DID NOT HOLD IN RATCHET INSERT DURING REMOVAL OF THE TEMP BASE; THIS CAUSED THE PATIENT TO ASPIRATE THE DRIVER AND EXPELLED IT AFTER COUGHING FIT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 20180869 ↗