TSX Implants TSX41B10Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 4.1MMD, 10MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant is a tooth implant placed in the jawbone. Its 104 reports, 94 of them injuries, often describe infection and bone loss around the implant, with pain and inflammation also reported and many implants removed afterward. There were no deaths, and 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
- 100
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00844868045090), received between Aug 9, 2023 and Sep 15, 2026 — classified as 91 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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 Problem89
- Component Missing5
- Failure to Osseointegrate2
- Detachment of Device or Device Component1
- Fracture1
- Mechanical Problem1
- Separation Failure1
- Separation Problem1
Patient problems
- Unspecified Infection63
- Osteolysis50
- Pain36
- Inflammation14
- No Clinical Signs, Symptoms or Conditions12
- Nerve Damage8
- Paresthesia8
- Swelling/ Edema8
Recent adverse event reports
The 25 most recent of 100 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 patient experienced numbness for a whole week, and therefore implants #29 and #31 were removed. Doctor reported nerve injury. Paresthesia and edema were also reported.
Patient problems: Nerve Damage; Numbness; Paresthesia
MAUDE report 50770627 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #23 was removed due to peri-implantitis. The patient presented with pain around the implant and swelling in the area. Clinical and radiographic examination revealed an infection at the implant site.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50769375 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis. Tooth site 16.Patient suffered from abscess, pain and inflammation.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50173981 ↗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: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25415340 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS, INFECTION. PATIENT WITH PAIN AND INFLAMMATION ON IMPLANT ZONE, IMPLANT REMOVED TO TREAT INFECTION. TOOTH SITE # 20. MEDICINE PRESCRIBED TO TREAT INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25230641 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO SINUS PERFORATION. PT WAS HAVING PAIN WHERE THE IMPLANT WAS PLACED- TOO CLOSE TO SINUS SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Sinus Perforation
MAUDE report 25175330 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. UPON UNCOVER THE IMPLANT WAS NOT INTEGRATED AND RED WITH INFLAMMATION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25124779 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT THE UN-COVERY, THE IMPLANT AT TOOTH SITE #14 WAS NOT INTEGRATED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 25019263 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 45 WAS REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24923024 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO INFECTION. IT WAS REPORTED THAT THE IMPLANT BECAME INFECTED AND LOOSE.
Patient problems: Unspecified Infection
MAUDE report 24900106 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 LACKED INTEGRATION DUE TO PERI-IMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24821157 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 FAILED DUE TO PERI-IMPLANTITIS AND BECAME MOBILE DURING THE FINAL HEALING ABUTMENT PROCEDURE. THE IMPLANT WAS REMOVED AND AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24734507 ↗MalfunctionMar 20, 2026Component Missing
THE DOCTOR REPORTS THAT THE IMPLANT CONTAINER ARRIVED EMPTY. IT DID NOT EVEN HAVE THE LABELS. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647534 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO A LOSS OF INTEGRATION AND A PERI-IMPLANTITIS. INFECTED, WITH A LINGUAL ABSCESS. LIGHT CURETTAGE WAS PERFORMED.PATIENT SUFFERED FROM ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24647119 ↗MalfunctionMar 6, 2026Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536159 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 FAILED TO INTEGRATE EIGHTEEN (18) MONTHS AFTER PLACEMENT. THE IMPLANT WAS SURGICALLY REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION AND PAIN.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24444101 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 24 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24405139 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH NUMBER 30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24193397 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 & #30 DEVELOPED PERI-IMPLANTITIS AFTER BEING RESTORED. THE IMPLANTS WERE REMOVED & THE SITES GRAFTED FOR FUTURE IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & INFLAMMATION
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24192251 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24053827 ↗MalfunctionDec 30, 2025Component Missing; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922202 ↗InjuryDec 26, 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 WAS REMOVED DUE TO BONE AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS EDEMA, AND INFLAMMATION.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23898194 ↗InjuryDec 26, 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; Pain; Unspecified Infection
MAUDE report 23897710 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO BONE LOSS AND INFECTION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23872236 ↗InjuryDec 20, 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 #20 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WAS INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 23858732 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page