Straumann TLX Implant System SLActive Roxolid TL (REF 035.3710S)Recalls & reported problems
Institut Straumann AG · TLX SP Implant, Ø 5.5mm WT, SLActive® 10mm, 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 dental implant is placed in the jawbone to hold a tooth replacement. Its 555 reports mostly describe the implant failing to bond with the jawbone or losing that bond. Patient effects include scar-like tissue, pain and infection. The reports include 555 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
- 562
- Deaths reported
- 0
- Injuries reported
- 562
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 562 adverse event reports that list this exact device (DI 07630031743206), received between Aug 12, 2021 and Sep 28, 2026 — classified as 562 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (329 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 Osseointegrate329
- Loss of Osseointegration111
- Adverse Event Without Identified Device or Use Problem110
- Difficult to Insert9
- Fracture3
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions253
- Fibrosis248
- Pain112
- Unspecified Infection57
- Hyperresponsive to stimuli24
- Inflammation19
- Swelling/ Edema15
- Hemorrhage/Blood Loss/Bleeding11
Recent adverse event reports
The 25 most recent of 562 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920151 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50920116 ↗InjurySep 18, 2026Difficult to Insert
Patient problems: Fibrosis
MAUDE report 50826378 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759221 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50738250 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719620 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50719617 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653508 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652918 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416134 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50414618 ↗InjuryAug 17, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 18, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with bone type IV and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50284259 ↗InjuryAug 17, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 18, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with bone type IV and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50281453 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain
MAUDE report 50259377 ↗InjuryAug 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Pain; Swelling/ Edema
MAUDE report 50258980 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in ADA 14. 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 50238522 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in ADA 14. 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 50238052 ↗InjuryAug 10, 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. 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 50199037 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6)2021 in ADA 19. On (b)(6)2026, loss of osseointegration was verified. 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 50198621 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2021 in ADA 19. On (B)(6) 2026, loss of osseointegration was verified. 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 50197167 ↗InjuryJul 30, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2023(b)(6) in FDI 36. On 2026(b)(6), loss of osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50089104 ↗InjuryJul 30, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2022(b)(6) in FDI 37. On 2026(b)(6), loss of osseointegration was verified. 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 50088881 ↗InjuryJul 27, 2026Fracture
The clinician reports the implant was inserted (b)(6)2023 in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6)2023, fracture of the implant was verified. 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 50042629 ↗InjuryJul 17, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 12. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 25859164 ↗InjuryJul 17, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 12. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 25858450 ↗
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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