TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS SLActive Roxolid TL (REF 033.602S)Recalls & reported problems
Institut Straumann AG · Standard Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™ · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann TL SLActive dental implant is a root-form implant placed in the jawbone. Most of the 843 reports describe implants that failed to bond with the bone, or lost that bond, and some mention infection, pain, tissue damage and inflammation. The reports record 843 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
- 844
- Deaths reported
- 0
- Injuries reported
- 844
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 844 adverse event reports that list this exact device (DI 07630031716224), received between Sep 9, 2019 and Sep 10, 2026 — classified as 844 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (534 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 Osseointegrate534
- Loss of Osseointegration260
- Adverse Event Without Identified Device or Use Problem41
- Difficult to Insert11
- Difficult to Remove3
- Defective Device1
- Fracture1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions371
- Fibrosis249
- Pain135
- Unspecified Infection118
- Tissue Damage111
- Inflammation66
- Swelling/ Edema41
- Hemorrhage/Blood Loss/Bleeding39
Recent adverse event reports
The 25 most recent of 844 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719694 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50653403 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2022 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: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50283885 ↗InjuryAug 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2024(b)(6) in FDI 26. 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 50259193 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2021 in FDI 36. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility and Swelling. No further patient complications were reported.
Patient problems: Fibrosis; Swelling/ Edema
MAUDE report 50199802 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 26. 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 50199293 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2014 in FDI 16. On 2026-07-01, 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 50120799 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50120267 ↗InjuryAug 3, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50120000 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 19. Details of surgery: Implant surface not completely covered with bone. 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 50119412 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 19. Details of surgery: Implant surface not completely covered with bone. 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 50118030 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in FDI 47, failure occurred upon insertion. 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 50088206 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 46. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type IV, fair oral hygiene and inadequate bone quality/quantity. 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 50011023 ↗InjuryJul 16, 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. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25845060 ↗InjuryJul 13, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 36. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 25800507 ↗InjuryJul 2, 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 25695040 ↗InjuryJun 25, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 36. 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 25627302 ↗InjuryJun 22, 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. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 25583716 ↗InjuryJun 22, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 46. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. 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 25581682 ↗InjuryJun 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 16. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. 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 25509060 ↗InjuryJun 11, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 16. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 25475979 ↗InjuryJun 11, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025 IN FDI 17. 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 25475592 ↗InjuryJun 4, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN THE PATIENT'S MOUTH. 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 25397411 ↗InjuryMay 28, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 37. 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 25320715 ↗InjuryMay 26, 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 25285036 ↗
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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