TSX Implants TSX37B13Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 3.7MMD, 13MML · Class 2 · Implant
Quick summary
This is a ZimVie TSX dental implant, a small screw-shaped root implant used to replace missing teeth. Most of the 75 reports describe implants that loosen and fail to stay in the jaw, with infection, bone loss around the implant, pain and inflammation around the gum; several mention implants having to be removed and bone grafts done. The reports describe 64 injuries and no deaths. Some also mention packaging that was not sealed and parts missing from the package. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00844868045069), received between Jun 29, 2023 and Sep 15, 2026 — classified as 59 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem59
- Unsealed Device Packaging5
- Component Missing3
- Separation Failure2
- Mechanical Problem1
Patient problems
- Unspecified Infection46
- Osteolysis36
- Pain19
- Inflammation13
- No Clinical Signs, Symptoms or Conditions11
- Erosion6
- Swelling/ Edema3
- Purulent Discharge2
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #16 was removed due to peri-implantitis, with associated bone loss and infection.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50769474 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #26 was removed due to peri-implantitis associated with significant bone loss.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50769120 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 7 was removed due to infection.
Patient problems: Unspecified Infection
MAUDE report 50264223 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient returned due to pus around the implant and severe bone loss. Implant was removed due to peri-implantitis. Noted Pain, inflammation and edema. Tooth site 9.
Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 50096386 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND ABSCESS.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25322838 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25322502 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #34 AND #36 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH OTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25305833 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT CAME IN BECAUSE CROWN WAS LOOSE, DOCTOR REMOVED AND CLEANED OUT INFECTION AND PACKED BONE TO BUILD UP BONE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25277868 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS SWELLING AND DRAINAGE AROUND IMPLANT AT TOOTH SITE #23. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Purulent Discharge; Unspecified Infection
MAUDE report 25086802 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE #32 WAS REMOVED DUE TO AN INFECTION.BONE TYPE: II.
Patient problems: Unspecified Infection
MAUDE report 25040684 ↗MalfunctionApr 3, 2026Separation Failure
IT WAS REPORTED THAT THE MOUNT WAS STUCK ON THE IMPLANT AT TOOTH SITE #23. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781195 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. THIS WAS AN IMMEDIATE IMPLANT (B)(6) PLACED AFTER EXT. FOR #11. HEALING WAS UNEVENTFUL, 3MO PA LOOKED ACCEPTABLE, I CHECKED TORQUE OF ENCODE HA PRIOR TO RELEASING PATIENT TO GP FOR RESTO. PATIENT REPORTED PAIN WHEN TORQUE FORCE APPLIED TO H. I REMOVED HEALING ABUTMENT AND NECROTIC BONE SEEN AT CORONAL 1/3 OF IMPLANT, IMPLANT REMOVED WITH HAND TORQUE WRENCH WITH LITTLE RESISTANCE. PROCEDURE COMPLETED USING ANOTHER IMPLANT, 4.1X11.5 IMPLANT REPLACED IMMEDIATELY FOLLOWING DEBRIDEMENT OF NECROTIC BONE 45 N-CM INSERTION TORQUE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24588746 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. PATIENT PRESENTED WITH PAIN, WE TAKE XRAY AND FOUND INFECTION AND BONE LOSS, IMPLANT WITH GRADE III MOBILITY. TOOTH SITE # 32.SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24446203 ↗MalfunctionFeb 24, 2026Separation Failure
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434386 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24333040 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24327387 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24283359 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24283275 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS CRESTAL BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #8. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 24267351 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #14 AND #15 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 24151420 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO PERI-IMPLANTITIS. NOTED FAILURE AT STAGE II. ADDITIONAL APPOINTMENT REQUIRED TO PLACE NEW IMPLANT FUTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24066259 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23991845 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23981926 ↗InjuryDec 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #14, #23, #34, AND #45 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23797625 ↗InjuryDec 4, 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; Unspecified Infection
MAUDE report 23720325 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.