TSX Implants TSX6B10Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 6.0MMD, 10MML · Class 2 · Implant
Quick summary
This TSX Implants dental implant is a root-form screw placed in the jaw to replace a tooth. The 49 reports mostly describe implants that became infected or loosened as surrounding bone was lost, so the implant had to be taken out, along with pain, swelling and inflammation around the site. There were 46 injuries and 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
- 50
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00844868045274), received between Nov 3, 2023 and Jul 30, 2026 — classified as 47 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (2 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 Problem45
- Device Misassembled During Manufacturing /Shipping2
- Detachment of Device or Device Component1
- Fracture1
- Mechanical Problem1
- Separation Problem1
Patient problems
- Unspecified Infection32
- Osteolysis27
- Pain16
- Inflammation7
- No Clinical Signs, Symptoms or Conditions4
- Swelling/ Edema3
- Abscess2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 30 was removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50081024 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN FOR IMPLANT RELEASE FOR THE IMPLANT AT TOOTH SITE #3. AN X-RAY SHOWED BONE LOSS AROUND THE IMPLANT AND THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: SENSITIVITY.
Patient problems: Hyperresponsive to stimuli; Osteolysis
MAUDE report 25161711 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT DROVE FAR TO COME TO THE OFFICE FOR TREATMENT AND HAD BEEN HAVING A LOT OF PAIN AND INFLAMMATION IN THE AREA FOR A FEW MONTHS BUT THOUGHT THAT IT WAS NORMAL. THE PATIENT PRESENTED FOR A FINAL IMPLANT CHECK AND INFECTION WAS DISCOVERED DURING THE EXAMINATION AND CONFIRMED WITH X-RAY IMAGING. THE IMPLANT WAS REMOVED AND THE PATIENT WAS PLACED ON ABX. THE PATIENT RETURNED FOR BONE GRAFTING A FEW WEEKS AFTER THE INFECTION WAS FULLY CLEARED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION AND PAIN.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24985710 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC TO EVALUATE THE IMPLANT AT TOOTH SITE #31. UPON EVALUATING THE IMPLANT SITE, BONE LOSS AND PERI-IMPLANTITIS WERE NOTED. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24931701 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT A SCHEDULED POST-OP APPOINTMENT, THE PATIENT CAME IN CONCERNED WITH STILL HAVING PAIN AROUND THE IMPLANT AT TOOTH SITE #14. A PA WAS TAKEN OF THE AREA AND VISUAL EXAM SHOWED PERI-IMPLANTITIS. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24926425 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. PATIENT CAME INTO OFFICE COMPLAINING OF PAIN AND A FUNNY TASTE IN HER MOUTH. PA TAKEN AND INFECTION DISCOVERED UPON EXAM. IMPLANT AND INFECTION REMOVED. PATIENT PLACED ON ABX AND RETURNED AT LATER DATE FOR BONE GRAFTING OF AREA. PATIENT WILL HAVE IMPLANT REPLACED AT LATER DATE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION & PAIN
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 24924910 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 BECAME LOOSE AND WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24598982 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH NUMBER 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24524160 ↗InjuryMar 2, 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 24477566 ↗InjuryFeb 25, 2026Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24443238 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A FOLLOW UP APPOINTMENT THERE WAS INFECTION, BONE LOSS AND PAIN AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24277598 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS REMOVED DUE TO PERI-IMPLANTITIS. DUE TO PERI-IMPLANTITIS IMPLANT WAS REMOVED SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24233029 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME INTO THE OFFICE FOR AN INTEGRATION CHECK AND WAS HAVING PAIN. THERE WAS PAIN TO THE TOUCH AND TISSUE AROUND THE IMPLANT AT TOOTH SITE #18. PANO SHOWED SIGNIFICANT BONE LOSS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND THE SITE WAS BONE GRAFTED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24192841 ↗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 #31 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23858909 ↗InjuryDec 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 #14 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23854562 ↗InjuryDec 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. (B)(6) 2025 PATIENT CAME INTO OFFICE TO EVAL IMPLANT. REFERRING DDS NOTICED SWELLING AND PUS. DDS PRESCRIBED AMOXICILLIN. PATIENT STATES IT HAS BEEN TENDER. SINCE CROWN WAS PLACED BY DDS. 2-4MM PROBING AROUND IMPLANT BUT NO SWELLING OR DRAINAGE AT THAT TIME. (B)(6) 2025 MORE BONE LOSS PRESENT AND CROWN IS LOOSE. IMPLANT REMOVED AND PLACED PUROS GRAFT. NEW IMPLANT PLACED ON (B)(6) 2025 SYMPTOMS AS A RESULT OF THE EVENT: SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 23769655 ↗InjuryNov 18, 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 23585808 ↗InjuryOct 17, 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23327788 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 22965348 ↗InjurySep 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: Sinus Perforation
MAUDE report 22951095 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 22936189 ↗InjuryAug 28, 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 #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT MOBILE, EXPLANTED AND GRAFTED FOR LATER PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22911067 ↗InjuryAug 23, 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 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22880300 ↗InjuryAug 11, 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
MAUDE report 22779797 ↗InjuryAug 11, 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
MAUDE report 22779769 ↗
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.