DS Implants 68015197Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07392532266300), received between Mar 22, 2024 and Jul 15, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Mechanical Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION WHERE THE DRILL BIT NO LONGER STAYS IN THE SHANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25825611 ↗
• MalfunctionJun 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER AND EXTENDER GOT STUCK DURING IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563787 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER EXTENDER DOES NOT HOLD THE DRILL BITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455700 ↗
• MalfunctionJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER EXTENDER DOES NOT HOLD THE DRILL BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455649 ↗
• MalfunctionApr 27, 2026Loose or Intermittent Connection; Material Deformation

  CUSTOMER REPORTED: DRIVER EXTENDER IS BENT, DOES NOT HOLD STEP DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998789 ↗
• MalfunctionApr 24, 2026Mechanical Problem

  A TOOL MALFUNCTION WAS REPORTED: THE EXTENSION DOES NOT HOLD THE INSERTED DRILL BIT AT ALL, AND IT FALLS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981894 ↗
• MalfunctionApr 8, 2026Mechanical Problem

  IT WAS REPORTED AN IMPLANT DRIVER STRIPPED AND THE EXTENDER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823374 ↗
• MalfunctionApr 8, 2026Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT DRIVER EXTENDER DOES NOT HOLD THE TOOL. IT HAS NOT YET BEEN USED AND WAS PURCHASED IN Q1 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818026 ↗
• MalfunctionFeb 25, 2026Mechanical Problem

  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 24445069 ↗
• MalfunctionJan 2, 2026Fracture; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CUSTOMER'S DRIVER WOULD NOT HOLD THE SCREW AND THE PEEK TIP FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950579 ↗
• InjuryMar 22, 2024Loose or Intermittent Connection; Detachment of Device or Device Component; Loose or Intermittent Connection; Detachment of Device or Device Component

  IN THIS EVENT IT IS REPORTED THAT IMPLANT DRILL EXTENDER CAME OUT AND THE PATIENT SWALLOWED THE DRILL. REPORTEDLY, THE DEVICE WAS EXPELLED OUT IN THE STOOL. AN ADVERSE FORM IS BEING SENT TO THE CUSTOMER FOR COMPLETION. THEY ARE ASKING FOR A RESPONSE TO THEIR COMPLAINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18959194 ↗