Straumann TLX Implant System SLActive Roxolid TL (REF 035.3508S)Recalls & reported problems
Institut Straumann AG · TLX SP Implant, Ø 4.5mm RT, SLActive® 8mm, Roxolid® · Class 2 · Implant
All models of Straumann TLX Implant System (132)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann TLX SLActive implant appears in 659 adverse event reports, with no deaths and 659 injuries. Reports mostly describe the implant not bonding with the jawbone, or losing that bond, with patients reporting fibrous tissue build-up, pain and infection. Reports rose over the last 12 months, to 178 from 122 in the 12 months before, and there are no recalls that 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
- 657
- Deaths reported
- 0
- Injuries reported
- 657
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 657 adverse event reports that list this exact device (DI 07630031743053), received between May 18, 2021 and Sep 28, 2026 — classified as 657 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (461 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate461
- Loss of Osseointegration131
- Adverse Event Without Identified Device or Use Problem64
- Difficult to Insert1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions324
- Fibrosis254
- Pain126
- Unspecified Infection81
- Inflammation32
- Hemorrhage/Blood Loss/Bleeding31
- Swelling/ Edema24
- Hyperresponsive to stimuli14
Recent adverse event reports
The 25 most recent of 657 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919806 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50807440 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761163 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50760374 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759952 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759261 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719611 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 26. On (b)(6) 2026, non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50481848 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. On (B)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480753 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480750 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 27. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50416339 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416182 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416130 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in the patient's mouth. On 2026(b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416129 ↗InjuryAug 20, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. Details of surgery: Sinus augmentation. On (b)(6) 2025, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50353685 ↗InjuryAug 20, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2022 in FDI 16. Details of surgery: Sinus augmentation. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type IV and inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50351895 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50283180 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Pain and Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50283088 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On 2026 (b)(6), non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Pain, Mobility and Hypersensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hypersensitivity/Allergic reaction; Pain
MAUDE report 50282438 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene and bruxism. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50282408 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50282153 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in FDI 27. Details of surgery: Ridge augmentation. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type IV. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282144 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2023 (b)(6) in ADA 4. On 2026 (b)(6), loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Pain and Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50281205 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. On 2026(b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50259492 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. On 2026-05-22, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258357 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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