TSX Implants TSX47B10Recalls & reported problems
ZimVie US Corp LLC · TSX™ IMPLANT, 4.7MMD, 10MML · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie TSX dental implant has 138 adverse event reports, with no deaths and 130 injuries. Many describe infection and bone loss around the implant, often leading to its removal, along with pain. No recalls name this device. Reports rose to 60 over the last year from 41 in the year before.
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
- 136
- Deaths reported
- 0
- Injuries reported
- 129
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00844868045151), received between May 15, 2023 and Sep 28, 2026 — classified as 129 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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 Problem128
- Unsealed Device Packaging4
- Patient-Device Incompatibility2
- Tear, Rip or Hole in Device Packaging2
- Component Missing1
- Fracture1
- Loss of Osseointegration1
- Mechanical Problem1
Patient problems
- Unspecified Infection93
- Osteolysis69
- Pain56
- Inflammation16
- No Clinical Signs, Symptoms or Conditions11
- Sinus Perforation8
- Swelling/ Edema8
- Abscess7
Recent adverse event reports
The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis at tooth site 26.Pain was reported as a consequence.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50914533 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site #1 was removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50768778 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient came to the clinic with discomfort in the area and suppuration due to an infection. Doctor decided to remove the implants. Tooth sites 14 & 16.
Patient problems: Discomfort; Purulent Discharge; Unspecified Infection
MAUDE report 50669089 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported the implant at tooth site 19 was removed due to infection.
Patient problems: Unspecified Infection
MAUDE report 50266416 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 21 was mobile 1 month post placement. Implant was removed due to peri-implantitis and pain.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50263917 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant was removed due to infection and bone loss. Loose implant 2 months after placement. Noted Bone Loss, inflammation, Abscess
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50172920 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis. Tooth site 37.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50017513 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT CAME IN TO CHECK ON HEALING WITH TENDERNESS AND VISIBLE SWELLING AROUND THE IMPLANT AT TOOTH SITE #3.OPTED FOR REMOVAL INSTEAD OF TREATMENT. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25476526 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # (B)(6) WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT. FLUCTUANT SWELLING AND ABSCESS.
Patient problems: Abscess; Swelling/ Edema; Unspecified Infection
MAUDE report 25462453 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE GENERAL DENTIST. THE PATIENT THOUGHT THAT THE ABUTMENT WAS LOOSE. WE SAW THE PATIENT, TOOK OUT THE HYBRID AND NOTICED THAT THE IMPLANT AT TOOTH SITE #30 WAS LOOSE. WE THINK IT WAS DUE TO THE PATIENT'S OCCLUSION. THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO PERIIMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25330343 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT RETURNED WITH INFECTION AROUND THE IMPLANT AT TOOTH SITE #14 AND THE IMPLANT NEEDED TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25247023 ↗InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT THE UN-COVER APPOINTMENT, THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO LOSS OF INTEGRATION AND PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25127698 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH NUMBER 30.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25059762 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS. MOBILE/LOOSE IMPLANT DISCOVERED AT ISQ APPOINTMENT, PATIENT WILL RETURN FOR IMPLANT PLACEMENT.
Patient problems: Osteolysis
MAUDE report 25027213 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT UN-COVERY, THE IMPLANT AT TOOTH SITE #2 WAS NOT STABLE AND INFECTION WAS PRESENT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24931656 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Osteolysis
MAUDE report 24924962 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 24916715 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN SITE #19 WAS REMOVED DUE PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24915988 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24911714 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT STATED THAT SHE HAD A SINUS INFECTION ON THE IMPLANT AT TOOTH SITE #3 AFTER CHRISTMAS AND IT NEVER WENT AWAY. CBCT IMAGING WAS TAKEN AND REPORTED AIR-FLUID LEVEL OF RIGHT MAXILLARY SINUS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Abscess; Inflammation; Unspecified Infection
MAUDE report 24899716 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 24821289 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. LOOSE IMPLANT. TOOTH NUMBER 14.
Patient problems: Osteolysis
MAUDE report 24747554 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24647935 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A BUMP ON THE GUMS AROUND THE IMPLANT AT TOOTH SITE #3 SINCE THE IMPLANT WAS PLACED. THE IMPLANT WAS MOBILE AND SINUS INFECTION WAS PRESENT. THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 24643300 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DISCOMFORT IN SINUS AREA, INFECTION REMOVED LACK/LOSS OF STABILITY. TOOTH NUMBER 2. IMPLANT REMOVAL DRAINAGE. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.
Patient problems: Discomfort; Swelling/ Edema; Unspecified Infection
MAUDE report 24592586 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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