Lava™ 2914A2-LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30605861040977), received between Feb 15, 2018 and May 22, 2018 — classified as 4 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A DENTAL PROFESSIONAL REPORTED THE CASE OF A (B)(6) YEAR-OLD FEMALE PATIENT (YOB (B)(6)) WHO REQUIRED ROOT CANAL TREATMENT ON TOOTH #18. THIS TOOTH HAD A LAVA ULTIMATE ONLAY PLACED ON (B)(6) 2014, BECAUSE A PRIOR AMALGAM RESTORATION ON THE TOOTH HAD FAILED AND DECAY WAS NOTED. AT THE TIME OF LAVA ULTIMATE CROWN PLACEMENT, THE PATIENT WAS MADE AWARE THAT ROOT CANAL TREATMENT MAY BE NEEDED IN THE FUTURE BECAUSE OF THE DEPTH OF THE DECAY UNDER THE AMALGAM. ON (B)(6) 2018, IT WAS REPORTED THAT ROOT CANAL TREATMENT WAS PERFORMED AND A NON-3M CROWN PLACED.

  Patient problems: No Code Available

  MAUDE report 7533213 ↗
• InjuryMay 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A DENTAL ASSISTANT REPORTED THE CASE OF A (B)(6) YEAR OLD MALE PATIENT WHO REQUIRED ROOT CANAL TREATMENT ON TOOTH #3. THIS TOOTH HAD A LAVA ULTIMATE CROWN SEATED ON (B)(6) 2014. ON (B)(6) 2016, IT WAS NOTED THIS TOOTH HAD DISCOLORATION AT MARGIN. NO VISIBLE LEDGE OR OVERHANG WAS NOTED. THE DENTAL ASSISTANT REPORTED THE TOOTH APPEARED DISCOLORED AND SOFT IN THE AREA THE CROWN DEBONDED. DECAY, AS A RESULT OF MICRO LEAKAGE, WAS NOTED INTO THE PULP CHAMBER WHICH HAD CAUSED THE PATIENT DISCOMFORT. AS A RESULT, ROOT CANAL TREATMENT WAS PERFORMED ON THAT SAME DAY AND AN ADDITIONAL TOOTH STRUCTURE WAS REMOVED REQUIRING A NEW CROWN TO BE PLACED.

  Patient problems: No Code Available

  MAUDE report 7476896 ↗
• InjuryMay 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A DENTAL ASSISTANT REPORTED THE CASE OF A (B)(6) YEAR OLD FEMALE PATIENT WHO REQUIRED ROOT CANAL TREATMENT ON TOOTH #4. THIS TOOTH HAD A LAVA ULTIMATE CROWN SEATED ON (B)_(6) 2013. ON (B)(6) 2018, THE CROWN DEBONDED. DECAY, AS A RESULT OF MICRO LEAKAGE, WAS NOTED INTO THE PULP CHAMBER WHICH HAD CAUSED THE PATIENT DISCOMFORT. AS A RESULT, ROOT CANAL TREATMENT WAS PERFORMED ON THAT SAME DAY AND AN ADDITIONAL TOOTH STRUCTURE WAS REMOVED REQUIRING A NEW CROWN TO BE PLACED.

  Patient problems: No Code Available

  MAUDE report 7476895 ↗
• InjuryFeb 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A DENTAL OFFICE REPORTED THAT FIVE PATIENTS (AGES AND GENDERS NOT PROVIDED) WITH A LAVA ULTIMATE RESTORATION REQUIRED ROOT CANAL TREATMENT DUE TO THE DISCOVERY OF RECURRENT DECAY. FURTHER PATIENT SPECIFIC INFORMATION ON THE DATE OF SEATING, DATE OF FAILURE, AND TOOTH HISTORY WAS NOT PROVIDED TO 3M.

  Patient problems: No Code Available

  MAUDE report 7274214 ↗