TSX Implants TSX31B10Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 3.1MMD, 10MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant is a small screw-shaped root implant placed in the jaw. The 32 reports describe implants that failed to integrate, became infected, or were gradually lost to bone loss and later removed, with pain, inflammation and swelling; a few mention unsealed packaging and one implant fracturing during placement. There were 30 injuries and no deaths, and no recalls name this device. Reports rose from 5 to 19 over the two 12-month periods.
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
- 32
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00844868044994), received between Oct 11, 2023 and Aug 18, 2026 — classified as 30 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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 Problem28
- Unsealed Device Packaging2
- Mechanical Problem1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection22
- Osteolysis19
- Pain8
- Inflammation5
- No Clinical Signs, Symptoms or Conditions4
- Swelling/ Edema2
- Abscess1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Patient-Device Incompatibility
It was reported after implant placement at tooth site 4, patient continued to have severe pain. This was a redo of a previously placed and failed implant. It was decided by patient and doctor to remove this implant to alleviate pain. Doctor indicated allergic reaction. Possible implant placement in the future.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 50300751 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #22 was removed due to infection. An abscess, pain, and swelling were reported as consequences.
Patient problems: Abscess; Swelling/ Edema; Unspecified Infection
MAUDE report 50034071 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO (2) IMPLANTS BECAME INFECTED FAILING TO INTEGRATE. THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. TOOTH LOCATIONS WERE NOT PROVIDED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25283410 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, MOBILITY AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25216826 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #25 WAS REMOVED DUE TO INFECTION. THE AREA WAS REGRAFTED AND A NEW IMPLANT WAS PLACED.
Patient problems: Unspecified Infection
MAUDE report 25171735 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT STATED PAIN AT SITE. XRAY'S SHOW BONE LOSS AT SITE 19 WARRANTING IMPLANT REMOVAL. WILL RETURN IN 3 MONTHS FOR REPLACEMENT. NOTED PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25152558 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE 8 HAD BONE LOSS AND WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 25027719 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 45+46 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24922937 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 35+34 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24922762 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24776172 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 14 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24605097 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24370000 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO POOR ORAL HYGIENE AND PLAQUE ACCUMULATION DURING TRAVEL LED TO PERI-IMPLANTITIS THE PATIENT NEGLECTED POST-SURGICAL CARE INSTRUCTIONS WHILE OUT OF THE REGION. THIS RESULTED IN EVENTUAL LOSS OF BOTH IMPLANTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24369901 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS RELEASED FOR RESTORATION ON (B)(6) 2025. THE PATIENT PRESENTED FOR A CROWN DELIVERY ON (B)(6) 2025 AND THE IMPLANT WAS DISCOVERED TO BE MOBILE AND PAINFUL WITH BONE LOSS NOTED ON THE PANOREX. THE PATIENT CAME TO OUR OFFICE SAME DAY. THE IMPLANT WAS RESTORED AND THE SITE WAS BONE GRAFTED. THE PATIENT IS EXPECTED TO RETURN IN FOUR MONTHS FOR A NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24210953 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974725 ↗InjuryDec 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: Pain; Purulent Discharge; Unspecified Infection
MAUDE report 23837987 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT STARTED HAVING PAIN AFTER CROWN PLACEMENT. THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23837733 ↗InjuryDec 11, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THEY THEY COULD NOT SEAT A HEALING ABUTMENT ONTO THE IMPLANT AT TOOTH SITE #12, THEN TRIED A HEALING COLLAR BUT IT WAS LOOSE. THE IMPLANT HAS A DAMAGED DRIVE FEATURE AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23779251 ↗InjuryNov 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 # 31 WAS REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23659008 ↗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: Unspecified Infection
MAUDE report 23414037 ↗InjuryOct 20, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION. TOOTH LOCATIONS ARE UNKNOWN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23343292 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT #6 WAS REMOVED FOR BONE LOSS. FOLLOW UP WITH PA SHOWED BONE LOSS, CONFIRMED WITH CT AND IMPLANT WAS MOBILE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 21605429 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PER INDICATED: PLACED IMPLANT IN SINUS GRAFT AND IT GOT INFECTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, ABSCESS, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: IMPLANT REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE NEW IMPLANT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO. SITE GRAFTED: ALLOGRAFT (B)(6) 2024. BONE DENSITY TYPE: UNKNOWN.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 21034659 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS, LOSS OF INTEGRATION, TOOTH # 10. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: FOLLOW UP. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: YES, NEW IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21034369 ↗InjuryOct 1, 2024Adverse 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 20343457 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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