Vulcan Custom Dental PRINT003Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00810033850066), received between Feb 5, 2025 and Sep 22, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (14 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Use of Device Problem

  Utilizing Surgical Guide, PRINT003, the doctor stated the implant did not take and it felt like "soft bone" at the implant site. Implant was removed, patient was grafted and sent home.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855326 ↗
• InjurySep 22, 2026Use of Device Problem

  Utilizing Surgical Guide, PRINT003, doctor attempted placing implant in site 18, but noticed afer placement the implant was loose and had to be backed out. Patient was grafted and sent home.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853375 ↗
• InjuryMay 11, 2026Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT 003, FINAL IMPLANT PLACEMENT IN LOCATION #7 DEVIATED FROM PLAN AND TERMINATED IN THE CORTICAL PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142482 ↗
• InjuryMay 4, 2026Use of Device Problem

  WHILE UTILIZING SURGICAL GUIDE PRINT003, IMPLANT PLACED IN LOCATION #27 APPEARS TO HAVE DEVIATED FROM THE PLAN'S FINAL PLACEMENT, IMPLANT WILL BE REMOVED AND PATIENT GRAFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068843 ↗
• MalfunctionMar 9, 2026Use of Device Problem

  WHILE UTILIZING SURGICAL GUIDE PRINT003, CLINICIAN NOTED THAT THE IMPLANT ANGULATION APPEARED OFF FROM THE INTENDED TRAJECTORY AND THE APICAL 1.5 MM PERFORATED THE BUCCAL PLATE INTO THE VESTIBULAR SPACE. IMPLANT WAS REMOVED; PATIENT WAS GRAFTED AND SENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545981 ↗
• MalfunctionAug 14, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT003, CLINICIAN FELT IMPLANT IN LOCATION #12 WAS PLACED TOO LINGUAL AND AS A RESULT, ENDED UP REMOVING IMPLANT AND GRAFTING PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806773 ↗
• MalfunctionJul 16, 2025Use of Device Problem; Use of Device Problem

  UTILIZING DENTAL SURGICAL GUIDE PRINT003, THE CLINICIAN REPORTED A DEVIATION ON SITE #3 INTO THE MAXILLARY SINUS OF ABOUT 2-3 MM FROM THE PLANNED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521649 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  WHILE UTILIZING DENTAL SURGICAL GUIDE PRINT 003, CLINICIAN WAS OFF TRAJECTORY WHEN DRILLING, CAUSING A PERFORATION OF THE BUCCAL PLATE. CLINICIAN GRAFTED THE PATIENT AND DID NOT ATTEMPT TO FINISH THE CASE AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359584 ↗
• MalfunctionJun 7, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT003, THE CLINICIAN REPORTED THE GUIDE SLEEVE FOR SITE #8 CAME OUT ON THE FIRST PASS OF THE TISSUE PUNCH. CLINICIAN ATTEMPTED TO PLACE GUIDE SLEEVE BACK IN AT THE CORRECT ORIENTATION BUT WAS UNSUCCESSFUL, SO DRILLING PATH WAS OFF, CREATING A LOOSE OSTEOTOMY. THERE WAS NO INSERTION TORQUE FOR THE IMPLANT, SO THE IMPLANT WAS REMOVED, PATIENT WAS GRAFTED AND SENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162613 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT003, CLINICIAN STATED THAT THE GUIDE SLEEVE "DEBONDED WITH LITTLE PRESSURE TO THE SLEEVE". SITE WAS INTENDED FOR IMMEDIATE IMPLANT PLACEMENT, BUT PATIENT WAS GRAFTED AND SENT HOME INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153598 ↗
• MalfunctionJun 4, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT003, SURGICAL GUIDE SLEEVE CAME LOOSE DURING DRILLING PROCESS, CLINICIAN DISCONTINUED PROCEDURE AS A RESULT OF THE LOOSE SLEEVE, GRAFTED THE PATIENT AND SENT THEM HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146118 ↗
• MalfunctionMay 15, 2025Use of Device Problem; Use of Device Problem

  WHILE UTILIZING SURGICAL GUIDE PRINT003, THE CLINICIAN BELIEVES THE 28MM DRILL JUST SKIMMED ON PALATAL BONE WHICH INDUCED LOTS OF BLEEDING. CLINICIAN FELT SOMETHING WAS "OFF" WITH THE GUIDE SO THE PROCEDURE WAS DISCONTINUED, PATIENT WAS GRAFTED AND SENT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031126 ↗
• MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT003, CLINICIAN STATED THE IMPLANTS DID NOT ENGAGE THE BONE, CLINICIAN ALSO COMMENTED THAT HIS IMPLANT DRIVER DID NOT ENGAGE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942037 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Use of Device Problem

  UTILIZING SURGICAL GUIDE PRINT 003, THE IMPLANT AT LOCATION 22 DID NOT TAKE IN THE BONE AND HAD TO BE BACKED OUT OF THE IMPLANT SITE. PATIENT LEFT WITH PLUG AT SITE AND NO IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317425 ↗