T3 T3PT6510Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00844868046813), received between Jun 8, 2023 and Sep 7, 2026 — classified as 49 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 50646758 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS. BONE LOSS NOTED DURING INSERTION OF THE FINAL RESTORATION OF THE IMPLANT. IMPLANT REMOVED WITH SITE DEBRIDEMENT. IMPLANT PLACEMENT AFTER 4 MONTHS HEALING.

  Patient problems: Osteolysis

  MAUDE report 25448824 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BONE LOSS WAS DISCOVERED ON THE MESIAL OF THE IMPLANT AT TOOTH SITE #30. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 25446773 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN COMPLAINING OF PAIN AROUND THE RESTORED IMPLANT AT TOOTH SITE #15. BONE LOSS WAS NOTED ON A RADIOGRAPH. THE IMPLANT WAS REMOVED AND REPLACED. THE PATIENT WILL RETURN FOR STABILITY TEST IN FOUR (4) MONTHS.

  Patient problems: Osteolysis; Pain

  MAUDE report 25445810 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE POST-OP APPOINTMENT, THE PATIENT'S BITE WAS SEVERELY OFF. THE IMPLANT AT TOOTH SITE #14 WAS PLACED IN THE WRONG AREA AND NEEDED TO ME REMOVED. THE IMPLANT HAS TO BE MOVED TO A DIFFERENT LOCATION. THE PATIENT WILL COME BACK FOR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330045 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. AFTER YEARLY CLEANING AND X-RAYS. NOTICED BONE LOSS AND PERI-IMPLANTITIS. TOOTH #18.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25246830 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. DISCOVERED DURING CLINICAL PROCEDURE. ON (B)(6) 2026 - IMPLANT #3 WITH VERTICAL BONE LOSS ON THE MESIAL TO THE 5TH THREAD AND VERTICAL BONE LOSS ON THE DISTAL TO THE 8TH THREAD. ON (B)(6) 2026 - # 3 - THE HEALING ABUTMENT WAS REMOVED. THE IMPLANT WAS REMOVED USING REVERSE TORQUE. A FULL THICKNESS PAPILLA SPARING FLAP WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. DECORTICATED. THE OSTEOTOMY WAS REFINED USING SHAPING DRILLS AND OSTEOTOMES. NO SCOUT FILM WAS OBTAINED. NO SURGICAL GUIDE WAS USED. A ZB T3 PRO TAPERED IMMEDIATE MOLAR 7 X 10 MM IMPLANT WAS PLACED. TORQUE >90 NCM. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE PERI-IMPLANT DEFECT. A COVER SCREW WAS PLACED. A PRF MEMBRANE WAS PLACED OVERLYING THE SITE. SOFT TISSUES WERE REAPPROXIMATED USING 3-0 GUT SUTURE.

  Patient problems: Osteolysis

  MAUDE report 25210125 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  No further event information is available at the time of this report.

  Patient problems: Osteolysis

  MAUDE report 25209900 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. ON (B)(6) 2025 THE PATIENT PRESENTED FOR A BONE GRAFT CHECK ON THE LOWER. UPON EXAMINATION, DARK LUCENCY WAS NOTICED AROUND THE IMPLANT. THE PHYSICIAN OPTED TO WAIT A MONTH TO CHECK THE AREA AGAIN AND UPON TORQUE TEST AND MANUAL MANIPULATION THE PATIENT FELT INTENSE PAIN ON (B)(6) 2026. THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25084655 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. SECOND STAGE PROCEDURE - RADIOGRAPH REVEALED RADIOLUCENCY MESIALLY/LAPICALLY PROBING >9MM, 4 WALL DEFECT CLINICALLY DETECTED, EXUDATE PRESENT, REMOVED IMPLANT WITH MINIMAL RESISTANCE. TOOTH NUMBER 18.

  Patient problems: Unspecified Infection

  MAUDE report 24591596 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort; Pain

  MAUDE report 24187674 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS. PATIENT REPORTED PAIN ASSOCIATED WITH IMPLANT #13. SYMPTOMS AS A RESULT OF THE EVENT WAS PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23867827 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE INTO THE BONE DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 23840333 ↗
• InjuryDec 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED AS THE HEX'S THREADS WERE STRIPPED/DAMAGED. WHILE PLACING A 6/5X10 (REF T3PT6510) IMPLANT, THE INTERNAL HEX WAS STRIPPED AND I COULD NO LONGER TORQUE THE IMPLANT DOWN OR REVERSE TORQUE THE IMPLANT OUT SINCE THE INTERNAL HEX WAS STRIPPED. THE CUSTOMER OPTED TO LEAVE THE STRIPPED IMPLANT IN SITU UNTIL REMOVAL TOOLS ARRIVED TO REPLACE THE IMPLANT. THE IMPLANT WAS ULTIMATELY REMOVED IN AN ADDITIONAL PROCEDURE ON (B)(6) 2025. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 23804385 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 CAME OUT DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 23429949 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 SHOWED PARULIS ON THE DISTAL WITH A 10 MM PROBING DEPTH. PERIAPICAL FILM CONFIRMED COMPLETE SEATING OF THE ABUTMENT WITH EVIDENCE OF BONE LOSS. THE HEALING ABUTMENT WAS REMOVED AND THE IMPLANT WAS REMOVED USING REVERSE TORQUE. A FULL THICKNESS FLAP WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUES DOWN TO HEALTHY BONE. THERE WAS A 2 MM BONY DEHISCENCE ON THE FACIAL. ALL OTHER BONY WALLS WERE NOTED TO BE INTACT. DECORTICATED. THE SITE WAS THEN PREPARED FOR IMPLANT PLACEMENT USING STANDARD DRILLING SEQUENCES AND PROTOCOLS THROUGH MANUFACTURER'S INSTRUCTIONS.

  Patient problems: Osteolysis

  MAUDE report 23429766 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Osteolysis

  MAUDE report 23306335 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23014527 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS. ON (B)(6) 2025 - PHONE CALL FROM LINDA FOLLOWING REMOVAL OF TOOTH #3 WITH IMMEDIATE IMPLANT AND INDIRECT SINUS AUGMENTATION ON (B)(6) 2025. SHE CALLED TODAY SAYING THAT HER IMPLANT FELL OUT. I ASKED HER IF SHE COULD SEND A PHOTO SO I COULD SHOW DR. LEE. AFTER RECEIVING THE PHOTO I SHOWED IT TO DR. LEE AND HE SAID WE WILL NEED TO SEE HER TO DEBRIDE THE AREA AND RE-GRAFT THE SITE WITH PRF. (B)(6) 2025 - #3- A FULL THICKNESS PAPILLA SPARING FLAP WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. THERE WAS A SLIGHT DEHISCENCE OF BUCCAL BONE NOTED. ALL OTHER BONY WALLS AND THE SINUS FLOOR REMAINED INTACT. OSTEOTOMES WERE THEN USED TO DISPLACE APICAL BONE SUPERIORLY. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS PLACED IN THE OSTEOTOMY AND ALSO DISPLACED SUPERIORLY. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE OSTEOTOMY. A PRF MEMBRANE WAS PLACED OVER THE GRAFT. SOFT TISSUES WERE REAPPROXIMATED WITH 3-0 GUT SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis

  MAUDE report 22882472 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 WAS REMOVED USING REVERSE TORQUE DUE TO BONE LOSS. PERIAPICAL FILM SHOWS BONE LOSS ALONG THE SURFACE OF THE IMPLANT. ABUTMENT WAS REMOVED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE.

  Patient problems: Osteolysis

  MAUDE report 22862852 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED USING REVERSE TORQUE DUE TO BONE LOSS. A FULL THICKNESS CRESTAL FLAP WAS REFLECTED. THE SITE WAS DEBRIDED OF SOFT TISSUE TO HEALTHY BONE. IMMATURE GRANULAR BONE WAS ENCOUNTERED AND REMOVED. ALL FOUR BONY WALLS WERE NOTED TO BE INTACT. THE SINUS FLOOR WAS NOTED TO BE INTACT.

  Patient problems: Osteolysis

  MAUDE report 22861727 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HAVE AN IMPLANT AT TOOTH SITE #14 UNCOVERED. THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22703613 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS. OCCLUSION TOO HIGH ON RESTORATION CAUSING LOOSENING OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 22289698 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR PERI-IMPLANTITIS AT TOOTH SITE #19. THE PATIENT WAS TREATED WITH LASER THERAPY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22284287 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22247797 ↗