DS Implants 68017003Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07392532268953), received between Feb 25, 2026 and Sep 30, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952426 ↗
• MalfunctionSep 21, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847575 ↗
• MalfunctionSep 4, 2026Fracture

  It was reported that the Implant Driver PEEK tip broke during use. No injury resulted.

  Patient problems: Insufficient Information

  MAUDE report 50611094 ↗
• MalfunctionJul 15, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER TIP WAS BROKEN. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830996 ↗
• MalfunctionJul 14, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25811199 ↗
• MalfunctionJun 9, 2026Fracture

  IT WAS REPORTED THERE WAS A TOOL ISSUE; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442862 ↗
• MalfunctionJun 2, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE TIP BROKE ON THE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364940 ↗
• MalfunctionJun 2, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION. THE TOOL WOULD NOT ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359535 ↗
• MalfunctionMay 27, 2026Fracture

  IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310618 ↗
• MalfunctionMay 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER PEEK WAS STUCK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215429 ↗
• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED AN IMPLANT DRIVER HAD A TOOL ISSUE; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156355 ↗
• MalfunctionApr 14, 2026Fracture

  CUSTOMER REPORTED A TOOL MALFUNCTION - PEEK TIP BROKEN: SESSION WAS COMPLETED SUCCESSFULLY, THE TOOL WAS IN USE FOR APPROX. 2-3 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873392 ↗
• MalfunctionMar 25, 2026Fracture

  CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687758 ↗
• MalfunctionMar 19, 2026Fracture

  THE BASIC HEADS OF THE IMPLANT DRIVER HAVE SHEARED OFF ON THE FULLY GUIDED IMPLANT DRIVER FOR THE S/L IMPLANT PLATFORMS AND THE M PLATFORM DRIVER FOR THE NON-GUIDED KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637727 ↗
• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION; HOWEVER, THE SESSION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445143 ↗