Straumann TLX Implant System SLA Roxolid TL (REF 035.2508S)Recalls & reported problems
Institut Straumann AG · TLX SP Implant, Ø 4.5mm RT, SLA® 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 implant is a dental implant placed in the jawbone to support a replacement tooth. All 281 reports are injury reports, mostly describing implants that did not bond with the bone, with some implants becoming loose and patients reporting pain and infection. There were no deaths, and 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
- 280
- Deaths reported
- 0
- Injuries reported
- 280
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 07630031742483), received between Jan 27, 2023 and Sep 28, 2026 — classified as 280 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (239 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 Osseointegrate239
- Loss of Osseointegration28
- Adverse Event Without Identified Device or Use Problem12
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- Fibrosis64
- Pain33
- Unspecified Infection32
- Swelling/ Edema5
- Hemorrhage/Blood Loss/Bleeding4
- Inflammation4
- Abscess2
Recent adverse event reports
The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921892 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921735 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720093 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719306 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50655341 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654269 ↗InjuryAug 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2021 in FDI 26. On (b)(6)2026, loss of osseointegration was verified. No product was returned to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503912 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415386 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50415308 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414411 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Swelling/ Edema
MAUDE report 50414271 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50259601 ↗InjuryAug 10, 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 50199274 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (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 50199251 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. Details of surgery: Sinus augmentation. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. 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 50198697 ↗InjuryAug 3, 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. No product was returned 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 50120372 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50120082 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 15. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50120076 ↗InjuryJul 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 50010754 ↗InjuryJul 6, 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 25722919 ↗InjuryJul 6, 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 25721481 ↗InjuryJun 25, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 46. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: BLEEDING, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Inflammation
MAUDE report 25626441 ↗InjuryJun 25, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 45. ON (B)(6) 2026, NON-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 25624314 ↗InjuryJun 24, 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 25611484 ↗InjuryJun 22, 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 AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 25583878 ↗
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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