3i T3® DCD® BNPS6513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868029441), received between Feb 21, 2023 and Feb 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 FAILED TO INTEGRATE DUE TO ALLERGIC WAS REMOVED. PATIENT EXPERIENCED SIGNIFICANT PAIN STEMMING FROM IMPLANT SITE. PATIENT TOOK MULTIPLE ROUNDS OF ANTIBIOTICS WITH NO RELIEF. PATIENT FOUND OUT FROM HER ORTHOPEDIC SURGEON SHE IS ALLERGIC TO TITANIUM AND IS HAVING ALL TITANIUM REMOVED FROM HER BACK AND REQUESTED IMPLANT REMOVAL AS WELL.  SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, PATIENT TOOK MULTIPLE ROUNDS OF ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA & INFLAMMATION.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema

  MAUDE report 16408848 ↗