TSX Implants TSX37B11Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 3.7MMD, 11.5MML · Class 2 · Implant
All models of TSX Implants (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant is a screw-shaped implant placed in the jawbone. Many of the 113 reports describe infection and bone loss around the implant, with implants becoming loose and being removed. The reports include 94 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
- 118
- Deaths reported
- 0
- Injuries reported
- 99
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00844868045052), received between Mar 17, 2023 and Sep 15, 2026 — classified as 99 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem90
- Packaging Problem10
- Fracture8
- Component Missing3
- Detachment of Device or Device Component3
- Mechanical Problem3
- Loss of Osseointegration1
- Separation Failure1
Patient problems
- Unspecified Infection67
- Osteolysis63
- No Clinical Signs, Symptoms or Conditions30
- Pain23
- Inflammation21
- Erosion6
- Swelling/ Edema3
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 118 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 #22 was removed due to peri-implantitis. During the uncovering appointment, movement of the implant was noted after placement of the healing abutment, and the implant was subsequently removed.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50770261 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with Grade II mobility of an IS bridge. Radiographic examination revealed significant bone loss. Clinical examination showed exposure of the implant threads. The patient was diagnosed with peri-implantitis. It was decided to remove the implants in order to perform guided bone regeneration (GBR) and subsequently place new implants. Tooth sites 11, 13, 22 and 23.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50690978 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50646879 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 27 was removed due to bone loss. Discovered during appointment to uncover implants, both implants were mobile.
Patient problems: Osteolysis
MAUDE report 50082604 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during appointment to uncover implant at tooth site 22, it was mobile due to excessive or progressive bone loss and was removed.
Patient problems: Osteolysis
MAUDE report 50055208 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during visit to uncover the implant, implant at tooth site 22 was mobile due to excessive or progressive bone loss and was removed.
Patient problems: Osteolysis
MAUDE report 50055075 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 FAILED FOUR (4) WEEKS AFTER PLACEMENT. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. POSSIBLE DIABETES RELATED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25461500 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS MOBILE AND SYMPTOMATIC. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25355752 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #45 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25278180 ↗InjuryMay 20, 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: EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 25230226 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 25153350 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO A PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25121357 ↗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 24922904 ↗MalfunctionApr 9, 2026Component Missing
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827530 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24809044 ↗InjuryMar 30, 2026Adverse 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, INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24717709 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE BUCCAL PLATE OF THE IMPLANT AT TOOTH SITE #11 WAS INFECTED/DEFECTIVE. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24642973 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A LOT OF PAIN. THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. PERIODONTAL DISEASE WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24628255 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE # 12,22,14, 24 WERE REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24589942 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 24489861 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24421636 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 24338758 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS NOT REPLACED AT THE TIME OF THE OPERATION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24271897 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 24028126 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED TO THE OFFICE WITH PAIN AND SWELLING TWO WEEKS AFTER THE PLACEMENT OF THE IMPLANT. THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 24008064 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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