DS PrimeTaper 68017259Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper Drill Sleeve 5 ND GS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07392532269974), received between Feb 9, 2026 and Sep 8, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Mechanical 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem4
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668108 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE INTERNAL SPRING OF THE METAL SLEEVE CAME LOOSE TWICE DURING INSTALLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459218 ↗MalfunctionApr 30, 2026Mechanical Problem
CUSTOMER REPORTED: THE SLEEVES' SPRING HAS BEEN EXPOSED UPON OPENING OF PRODUCT FROM PACKAGE. UNUSED PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25053207 ↗MalfunctionMar 26, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS NO FIT AT INITIAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703236 ↗MalfunctionMar 19, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A FITTING PROBLEM. ANOTHER ITEM WAS USED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639564 ↗MalfunctionMar 18, 2026Mechanical Problem
IT WAS REPORTED THAT THE ITEM DID NOT FIT ON INITIAL USE. ANOTHER ITEM WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634676 ↗MalfunctionFeb 9, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION. THE WIRE OF AN UNUSED SLEEVE CAME OFF; THIS WAS DISCOVERED AFTER ATTACHING IT TO THE INSTRUMENT AND WAS DETERMINED TO HAVE OCCURRED AFTER STERILIZATION AND BEFORE SURGERY. THE SESSION WAS COMPLETED ON THE SAME DAY WITHOUT ANY PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291659 ↗
Other Accessories, implant, dental, endosseous devices
- N/A 68015189Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous388 reports
- N/A 68015191Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous319 reports
- N/A 68015193Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous283 reports
- N/A 68015187Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous266 reports
- N/A 68015188Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous185 reports
- N/A 68015192Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous159 reports
- N/A 68015190Dentsply Implants Manufacturing GmbH · Accessories, implant, dental, endosseous147 reports
- NobelReplace® 37045Nobel Biocare AB · Accessories, implant, dental, endosseous2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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