TSX Implants TSX41B8Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 4.1MMD, 8MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant is a small screw-shaped titanium post used to anchor a replacement tooth in the jawbone. The 44 reports mostly describe implants that failed to heal into the bone or became infected, with patients reporting pain, swelling, pus, and bone loss around the implant site, and several implants having to be removed by a dentist; one report describes a package arriving empty. There were 43 injuries and no deaths. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00844868045144), received between Jun 13, 2023 and Sep 15, 2026 — classified as 44 injuries, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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 Problem41
- Component Missing1
- Migration1
- Separation Failure1
- Use of Device Problem1
Patient problems
- Osteolysis26
- Unspecified Infection23
- Pain9
- Inflammation7
- No Clinical Signs, Symptoms or Conditions5
- Discomfort2
- Erosion2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 45 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 an infection at the implant site.
Patient problems: Unspecified Infection
MAUDE report 50770671 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REPORTED PAIN AROUND THE IMPLANTS AT TOOTH SITES #3 AND #4. SUSPECTED SINUS PERFORATION AND THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Sinus Perforation
MAUDE report 25413931 ↗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 25305372 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO BONE LOSS. PATIENT CAME IN 3 MONTHS LATER, X-RAY TAKEN SHOWED BONE LOSS AROUND IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: SENSITIVITY.
Patient problems: Hyperresponsive to stimuli; Osteolysis
MAUDE report 25247531 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 BECAME INFECTED ONE (1) WEEK POST OP AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25027225 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 LACKED INTEGRATION DUE TO PERI-IMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE. GRAFT PLACED WITH IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24820995 ↗MalfunctionApr 8, 2026Component Missing
IT WAS REPORTED THAT THE PACKAGING CAME EMPTY. NO IMPLANT RECEIVED. PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815314 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24679888 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT RETURNED WITH THE IMPLANT IN THE COMPLETE REMOVABLE SUPRA-IMPLANT PROSTHESIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24524414 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24523702 ↗InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. IT WAS DETERMINED THAT THREADS WERE EXPOSED ON THE X-RAY. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT AND MOBILITY.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 24153106 ↗InjuryDec 3, 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: Inflammation; Pain; Unspecified Infection
MAUDE report 23708354 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE WORKING ON THE PATIENT'S DENTURE, THEY NOTICED THAT THE IMPLANT AT TOOTH SITE #4 WAS LOOSE AND WHEN THEY ENGAGED THE DENTURE, THE IMPLANT GOT PUSHED INTO THE SINUS. WE SEDATED THE PATIENT AND REMOVED THE IMPLANT. LAID GRAFT BONE AND PLACED THE PATIENT ON ANTIBIOTIC, AUGMENTIN.
Patient problems: Sinus Perforation
MAUDE report 23693038 ↗InjuryNov 25, 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 #44, #45, AND #46 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Pain
MAUDE report 23647246 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHEN THE DENTIST TRIED TO EXTRACT ANOTHER TOOTH BY THE IMPLANT AT TOOTH SITE #14, BONE LOSS WAS DETECTED AND THE IMPLANT CAME OUT.
Patient problems: Osteolysis
MAUDE report 23555781 ↗InjuryOct 29, 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 #21 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23417941 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME INTO THE OFFICE STATING THAT THE IMPLANT AT TOOTH SITE #14 FELL OUT OF THEIR MOUTH. THE IMPLANT WAS NON-INTEGRATED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA & IRRITATED TISSUE.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23417858 ↗InjuryOct 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415305 ↗InjuryOct 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 DUE TO PERI-IMPLANTITIS. TOOTH SITE (UNKNOWN). PATIENT HAD PAIN, AND ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23351966 ↗InjuryAug 4, 2025Migration; Migration
IT WAS REPORTED A LACK OF PRIMARY STABILITY OBSERVED DURING THE CLINICAL PROCEDURE AT TOOTH SITE 15 WITH MIGRATION INTO SINUS. IMPLANT WAS REMOVED. DOCTOR WILL WAIT FOR HEALING TO PLACE A NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708231 ↗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 #13 WAS PLACED WITH TORQUE OF ONLY 25NCM. THE PATIENT COMPLAINED OF PAIN AND ONE (1) WEEK LATER, A PA TAKEN AND THE IMPLANT WAS LOOSE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22210526 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING PAIN SINCE THE PLACEMENT OF THE IMPLANTS AT TOOTH SITES #26 AND #30. THE IMPLANTS WERE REMOVED DUE TO PAIN.
Patient problems: Pain
MAUDE report 22158361 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES 26/27 OBSERVED DURING THE CLINICAL PROCEDURE. THE PROCESS WAS NOT COMPLETED WITH OTHER IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21958629 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21619382 ↗InjuryMar 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 #30 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND DISCOMFORT.
Patient problems: Discomfort; Erosion; Unspecified Infection
MAUDE report 21560915 ↗
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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