DS Implants 68017002Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Implant Driver EV (M) ND GS · Class 1
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07392532268960), received between Dec 16, 2025 and Sep 24, 2026 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 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.
Reports received per month
Most reported problems
Device problems
- Fracture17
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890146 ↗InjuryJul 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067220 ↗MalfunctionJun 18, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. SESSION WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25549498 ↗MalfunctionJun 16, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION WHERE THE DRIVER DOES NOT SECURELY HOLD THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518763 ↗MalfunctionJun 9, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER TIP BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442915 ↗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 25364927 ↗MalfunctionMay 28, 2026Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT DRIVER DID NOT HOLD THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322833 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310909 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED AN IMPLANT DRIVER PEEK BROKE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310853 ↗MalfunctionMay 15, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED. THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186000 ↗InjuryApr 22, 2026Fracture
CUSTOMER REPORTED FRACTURE OF PEEK ARE AT THE INITIAL USE. NEW ITEM HAS BEEN USED AND SESSION COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958502 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEAK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957102 ↗MalfunctionApr 9, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT DRIVER PEEK TIP BROKE DURING USE. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830929 ↗MalfunctionMar 30, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24737567 ↗MalfunctionMar 25, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688492 ↗MalfunctionMar 25, 2026Fracture
CUSTOMER REPORTED THE FRACTURE OF AN IMPLANT DRIVER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687570 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A BROKEN IMPLANT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846958 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A CUSTOMER EXPERIENCED A BROKEN IMPLANT DRIVER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23846954 ↗MalfunctionDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THERE WAS A TOOL MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824325 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.