TSX Implants TSX41B13Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 4.1MMD, 13MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This TSX Implants TSX41B13 is a small screw-shaped dental implant used to anchor a tooth replacement. The 53 reports mostly describe implants loosening and being taken out after infection around the implant, bone loss, pain, and swelling, with a couple of fractured implants and one unsealed package. Fifty reports describe injuries and no deaths. No recalls name this device, and the report count is similar to the previous12 months.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00844868045113), received between May 11, 2023 and Aug 25, 2026 — classified as 45 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem2
- Unsealed Device Packaging1
Patient problems
- Unspecified Infection32
- Osteolysis28
- Pain14
- No Clinical Signs, Symptoms or Conditions6
- Inflammation5
- Erosion4
- Swelling/ Edema3
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Unsealed Device Packaging
It was reported an implant label issue with customer. Doctor reported that he noticed the seal was slightly peeled off over the implant and cover screw. He chose not to use it for fear that it may not have been sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50425667 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 5 was removed due to infection.
Patient problems: Unspecified Infection
MAUDE report 50264897 ↗InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS PLACED IN THE POSITION FOR AN IMPLANT RETAINED, DENTURE (REMOVABLE). THE PATIENT DEVELOPED PERI-IMPLANTITIS. ELECTED TO REMOVE AND REPLACE TWO (2) ADDITIONAL IMPLANTS IN AN ALTERNATE POSITION WHICH TREATED THE PROBLEM. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 25284062 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #7 AND #8 WERE REMOVED DUE TO BONE LOSS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: Osteolysis
MAUDE report 24888653 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24865444 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE #25. IMPLANT WAS REMOVED. NO OTHER IMPACT ON THE PATIENT REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24615013 ↗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 24589784 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT IN CLINIC TO GET REVISION SURGERY DUE TO BONE BEING TO HIGH IN LOWER ARCH TO GET LOWER DENTURE LUBRICATED. (DUE TO SUPRAERUPTION OF THE MANDIBULAR ARCH AND ASSOCIATED BONE IRREGULARITIES, IMPLANT WAS REMOVED. A MANDIBULAR ARCH ALVEOLECTOMY WAS PERFORMED, AND NEW IMPLANT WAS PLACED. SITE AFFECTED #30. WILL RETURN IN 5 MONTHS TO TEST NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378010 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT IN CLINIC TO GET REVISION SURGERY DUE TO BONE BEING TO HIGH IN LOWER ARCH TO GET LOWER DENTURE LUBRICATED. (DUE TO SUPRAERUPTION OF THE MANDIBULAR ARCH AND ASSOCIATED BONE IRREGULARITIES, IMPLANT WAS REMOVED. A MANDIBULAR ARCH ALVEOLECTOMY WAS PERFORMED, AND NEW IMPLANT WAS PLACED. SITE AFFECTED #19. WILL RETURN IN 5 MONTHS TO TEST NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377916 ↗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 24338750 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT IS PART OF ALL ON 4....PATIENT SEEN AT REQUEST OF DDS DUE TO THE POSSIBILITY OF UPPER TEMPORARY DENTURE BEING CRACKED. REMOVED IMPLANT AND PLACED NEW IMPLANT THE SAME DAY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24200402 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WAS HAVING SENSITIVITY AROUND HER IMPLANT. A PANOREX AND CBCT WERE TAKEN AND AN INFECTION WAS PRESENT AT THE SITE. THE IMPLANT WAS REMOVED. A NEW IMPLANT WILL BE PLACED IN THE FUTURE. TOOTH NUMBER 31.
Patient problems: Hyperresponsive to stimuli; Unspecified Infection
MAUDE report 23989049 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO INFECTION. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND ABSCESS.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 23980404 ↗InjuryDec 13, 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 #14, #23, #34, AND #45 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23797580 ↗InjuryNov 25, 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; Swelling/ Edema; Unspecified Infection
MAUDE report 23651100 ↗InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS PLACED IN THE WRONG POSITION. TOOTH NUMBER 27.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532937 ↗InjuryOct 22, 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; Unspecified Infection
MAUDE report 23361495 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #6 AND #11 WERE REMOVED DUE TO INFECTION. PATIENT HAD INFECTIONS ON IMPLANTS DURING CBCT NOTED. REMOVED IMPLANTS USING ZIMMER TORQUE SYSTEM. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT REPORTED. ADDITIONAL APPOINTMENT REQUIRED: YES, DELIVERY ON MAXILLARY HYBRID WITH PLACING TWO NEW IMPLANTS LATER AT #6 AND #11 SITES.
Patient problems: Pain; Unspecified Infection
MAUDE report 23361280 ↗InjurySep 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 #9 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23066364 ↗InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REPORTED NUMBNESS AROUND THE IMPLANT AT TOOTH SITE #28, AND UPON RETURNING; IT WAS OBSERVED THAT THERE WAS NO OSSEOINTEGRATION. THE IMPLANT WAS REMOVED DUE TO NERVE DAMAGE AND BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN
Patient problems: Nerve Damage; Osteolysis; Pain
MAUDE report 22685520 ↗InjuryJul 15, 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 #9 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 22506207 ↗InjuryJul 1, 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 LOCATION IS UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22370448 ↗InjuryMay 21, 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS. FAILED TORQUE TEST SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22061969 ↗InjuryMay 15, 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 #29 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFECTION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22031089 ↗InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21843353 ↗
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- 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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