TSX Implants TSX47B13Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 4.7MMD, 13MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant, a root-form screw placed in the jaw, appears in 36 adverse event reports, all describing injuries and no deaths. Most reports describe infection around the implant (30 reports), bone loss (22), pain (13), and swelling or inflammation, with several implants loosening or having to be removed. No recalls name 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00844868045175), received between Mar 25, 2024 and Jun 5, 2026 — classified as 35 injuries.
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. 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 Problem35
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection30
- Osteolysis21
- Pain13
- Inflammation4
- Erosion3
- Abscess1
- Hypersensitivity/Allergic reaction1
- Nerve Damage1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25415013 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 46 AND 47 WAS REMOVED DUE TO AN INFECTION.PATIENT SUFFERED FROM PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24949403 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 46 AND 47 WAS REMOVED DUE TO AN INFECTION. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24949402 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME BACK FOR A RECHECK AND HAD PURULENT DRAINAGE AROUND THE IMPLANT AT TOOTH SITE # (B)(6). THE IMPLANT WAS ALSO MOBILE. THE AREA WAS DEBRIDED AND THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24877861 ↗InjuryFeb 3, 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 24245343 ↗InjuryJan 14, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 23 AND 26 WERE LOOSE, EASY TO UNSCREW AND REMOVED DUE TO INFECTION AND ALLERGIC REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 24065764 ↗InjuryDec 17, 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 23827940 ↗InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A VISIT STATING THAT A BLISTER HAS FORMED ON THE PALLATE NEAR THE IMPLANT AT TOOTH SITE #8. IT WAS DETERMINED THAT THE IMPLANT FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23777280 ↗InjuryNov 10, 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: Unspecified Infection
MAUDE report 23510721 ↗InjuryOct 27, 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: Unspecified Infection
MAUDE report 23389684 ↗InjuryOct 27, 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 23389554 ↗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 # 5 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT CAME FOR TORQUE TEST ON IMPLANT # 5. IMPLANT WAS MOBILE. DR. REMOVED IMPLANT AND REPLACED IT WITH A DIFFERENT ONE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23019930 ↗InjuryAug 29, 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: Nerve Damage; Numbness
MAUDE report 22926808 ↗InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH SITE # 36.
Patient problems: Osteolysis
MAUDE report 22880280 ↗InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DENTAL IMPLANTS WERE REMOVED DUE TO INFECTION AND BONE LOSS AT TOOTH SITE # 44-17.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22880263 ↗InjuryAug 20, 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 22849786 ↗InjuryAug 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: Erosion; Pain; Unspecified Infection
MAUDE report 22704455 ↗InjuryAug 1, 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: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 22687547 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE #35.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22529145 ↗InjuryJul 16, 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 #27 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22524475 ↗InjuryJul 16, 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 #5 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 22518461 ↗InjuryJun 16, 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. BONE LOSS, IMPLANT WAS FOUND TO NO BE STABLE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22215155 ↗InjuryJun 16, 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 #12 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. BONE LOSS, IMPLANT WAS FOUND TO NO BE STABLE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22214994 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD REDNESS AROUND THE IMPLANT AT TOOTH LOCATION # 5 DUE TO INFECTION. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21726604 ↗InjuryMar 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 #UNK WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 21646638 ↗
Other Implant, Endosseous, Root-Form devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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