Surgical Guide Dental Implantation Drilling Template-Custom Made Surgical GuideRecalls & reported problems
3d Diagnostix, Inc. · Surgical Guide is intended to be used as an aid in the surgical placement of endosseous dental implants. Surgical guide allows a dental surgeon to place an implant in a very specific, pre-planned location to give the most ideal depth, angulation, and size of implant to fit the space. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850073333020), received between Mar 18, 2026 and Jul 8, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
- Positioning Failure1
- Use of Device Problem1
Patient problems
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Improper or Incorrect Procedure or Method
THE IMPLANT POSITION WAS TOO CLOSE TO THE #23 AND IT PERFORATED LINGUAL PLATE.
Patient problems: Failure of Implant
MAUDE report 25751648 ↗InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR HAS TO REMOVE THE GUIDE TO PUSH THE IMPLANT FOR MORE DEPTH.
Patient problems: Failure of Implant
MAUDE report 25360984 ↗InjuryMay 7, 2026No Apparent Adverse Event
TWO IMPLANTS HAVE FAILED A MONTH AFTER PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 25111370 ↗MalfunctionMay 7, 2026Use of Device Problem
DOCTOR MENTIONED THAT THE GUIDE DID NOT STOP HER FOR THE PILOT SITE AND WENT WAY DEEPER THAN PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111332 ↗MalfunctionMay 7, 2026Improper or Incorrect Procedure or Method
THE GUIDE DID NOT POSITION THE IMPLANT IN BONE 1/2 OFF THE PILOT DRILL WAS LINGUAL TO THE BONE. THERE WAS A 5 MM WIDTH OF BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111315 ↗InjuryMar 18, 2026Positioning Failure
THE IMPLANT ON SITE #12 WAS VERY CLOSE TO ADJACENT TOOTH AND HAD TO BE REMOVED AND GRAFTED.
Patient problems: Failure of Implant
MAUDE report 24626529 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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