TSX Implants TSX54B11Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 5.4MMD, 11.5MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This TSX dental implant, a 5.4 mm wide, 11.5 mm long root-form screw placed in the jaw, appears in 30 adverse event reports, all involving injuries and no deaths. Most reports describe implants that had to be taken out after placement because of infection, pain, swelling, bone loss around the implant, or a feeling that it was too large or loose. Reports dropped from 13 in the prior 12 months to 5 in the most recent 12 months. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00844868045229), received between Feb 8, 2023 and Aug 18, 2026 — classified as 29 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (4 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 Problem27
- Mechanical Problem4
Patient problems
- Unspecified Infection16
- Pain11
- Osteolysis9
- Inflammation6
- No Clinical Signs, Symptoms or Conditions6
- Swelling/ Edema3
- Erosion2
- Numbness2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 30 was removed due to numbness. Discovered during clinical procedure. Rescheduled appointment.
Patient problems: Numbness
MAUDE report 50299428 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WITH INFECTION 15 DAYS POST PLACEMENT. TOOTH SITE # 45. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 25230952 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CALLED STATING THAT THE IMPLANT AT TOOTH SITE #3 FELT TOO LARGE, AND THAT THEY WERE HAVING DISCOMFORT. THE IMPLANT WAS REMOVED AND REPLACED WITH A DIFFERENT SIZED ZIMMER IMPLANT. THE PATIENT WAS SCHEDULED TO RETURN FOR AN INTEGRATION EXAMINATION ON (B)(6) 2026. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24423724 ↗InjuryNov 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 #3 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23606582 ↗InjuryNov 17, 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; Sinus Perforation; Unspecified Infection
MAUDE report 23572812 ↗InjuryOct 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 #UNK WAS REMOVED DUE TO AN INFECTION. LIMITED EXAM.
Patient problems: Unspecified Infection
MAUDE report 23344500 ↗InjuryAug 27, 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 BECAME PAINFUL AND MOBILE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22902350 ↗InjuryAug 6, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726007 ↗InjuryJul 8, 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. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22439002 ↗InjuryJun 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 #30 AND #31 WERE REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22205560 ↗InjuryJun 2, 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 #18 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22128073 ↗InjuryMay 24, 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 INFECTION. THE SITE WAS DEGRANULATED AND SITE PRESERVATION WAS PERFORMED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND EDEMA.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 22081976 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD PAIN IN SITE. REMOVED IMPLANT, WILL GRAFT AND DELAYED IMPLANT PLACEMENT. TOOTH SITE: 3.
Patient problems: Pain
MAUDE report 21934425 ↗InjuryApr 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: Osteolysis; Swelling/ Edema
MAUDE report 21761638 ↗InjuryFeb 25, 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 BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 21459347 ↗InjuryJan 2, 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 #19 AND 31 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21061723 ↗InjuryDec 6, 2024Adverse 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 BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Pain
MAUDE report 20868537 ↗InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED THREE WEEKS AFTER SURGERY WITH DISCOMFORT AND SWELLING. WHEN IMPLANT AND ABUTMENT WERE EXAMINED, A HAND DRIVER WAS USED TO ATTEMPT TO TIGHTEN ABUTMENT AND THERE WAS MOVEMENT WITH THE IMPLANT. TOOTH 19. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, INFLAMMATION, PAIN. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: ANTIBIOTICS AND IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED: YES, NEW IMPLANT WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO. SITE GRAFTED: ALLOGRAFT PLACED PRIOR TO IMPLANT PLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 20722635 ↗InjuryOct 16, 2024Adverse 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 INFECTION. PATIENT CAME IN FOR A POST OPERATIVE APPOINTMENT TO CHECK IMPLANTS BEFORE SHE RETURNS TO HER GENERAL DENTIST TO HAVE # 30 IMPLANT CROWN FABRICATED; AN X-RAY WAS OBTAINED AND IT SHOWED THAT THERE IS AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20464171 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD NUMBNESS TO THE LIP AND CHIN DUE TO NERVE INJURY. THE IMPLANT AT TOOTH LOCATION #20 WAS REMOVED USING AN IMPLANT DRIVER AND BONE GRAFT WAS PLACED.
Patient problems: Nerve Damage; Numbness
MAUDE report 20293072 ↗InjuryJul 22, 2024Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801820 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SWELLING AND ABSCESS AROUND THE BASE OF THE IMPLANT EIGHTEEN (18) DAYS AFTER IMPLANT PLACEMENT AT TOOTH LOCATION #30. THERE WAS NO DRAINAGE AT THAT TIME. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TOR INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & SWELLING.
Patient problems: Erosion; Swelling/ Edema; Unspecified Infection
MAUDE report 19668267 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED EIGHT (8) DAYS BEING TREATED WITH ANTIBIOTICS WITH THE SAME SWELLING & INFECTION. THE IMPLANT WAS MOBILE AND WAS REMOVED DUE TO INFECTION. CLEANED THE AREA & PLACED BONE GRAFT. GAVE THE PATIENT ANOTHER ROUND OF ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & INFLAMMATION.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19667832 ↗InjuryJun 11, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE THREADS WERE EXPOSED ON THE IMPLANT AT TOOTH LOCATION # 18 AND THE SITE HAD A PERIODONTAL DEFECT DISTAL TO THE IMPLANT THAT NEVER HEALED PROPERLY. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512231 ↗MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19221836 ↗
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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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