T3® PRO Immediate Molar Implant T3PIM9D8LRecalls & reported problems
ZimVie US Corp LLC · T3® PRO Immediate Molar Implant, 9mmD, 8mmL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868047667), received between Apr 11, 2026 and May 18, 2026 — classified as 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Osteolysis2
- Abscess1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. PATIENT RETURNED TO CLINIC FOR TORQUE TEST AND IMPLANT WAS LOOSE. AREA #14 WILL NEED 4 MONTHS TO HEAL BEFORE ANOTHER ATTEMPT.
Patient problems: Osteolysis
MAUDE report 25209980 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS NOTED WITH BONE LOSS AND HAD TO BE REMOVED. A FULL THICKNESS FLAP WAS REFLECTED. THE OSTEOTOMY WAS DEBRIDED OF ALL SOFT TISSUE DOWN TO HEALTHY BONE. THERE WAS COMPLETE DEHISCENCE NOTED OF THE BUCCAL PLATE. ALL OTHER BONY WALLS AND THE SINUS FLOOR WERE NOTED TO BE INTACT. DECORTICATED. CO/CA/XE REGENEROSS BONE MIXED WITH PRF EXUDATE WAS USED TO GRAFT THE OSTEOTOMY. AN OSSEOGUARD FLEX MEMBRANE WAS PLACED OVER THE BUCCAL DEFECT. A PRF MEMBRANE WAS PLACED OVER THE SITE. SOFT TISSUES WERE REAPPROXIMATED WITH 3-0 CHROMIC SUTURE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Abscess; Osteolysis; Pain
MAUDE report 25007557 ↗InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN WITH A POST-OPERATIVE INFECTION AT THE IMPLANT OF TOOTH SITE #30. IT WAS ALSO NOTED THAT THE IMPLANT HAD LOOSENED. IT WAS REMOVED DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT WILL RETURN IN THREE MONTHS TO COMPLETE THE PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 24852519 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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