TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS SLActive Roxolid TL (REF 033.612S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.8mm WN, SLActive® 10mm, Roxolid®, Loxim™ · Class 2 · Implant
Quick summary
This Straumann SLActive implant is placed in bone. Reports mostly describe the implant failing to bond with the surrounding bone, along with pain, tissue damage, and infection. There are 7,662 reports, with no deaths and 7,662 injuries. 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
- 7,690
- Deaths reported
- 0
- Injuries reported
- 7,690
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,690 adverse event reports that list this exact device (DI 07630031716262), received between Aug 29, 2019 and Sep 28, 2026 — classified as 7,690 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,088 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
- Failure to Osseointegrate4,088
- Loss of Osseointegration2,988
- Adverse Event Without Identified Device or Use Problem528
- Difficult to Insert87
- Separation Failure19
- Difficult to Remove14
- Fracture7
- Therapeutic or Diagnostic Output Failure6
Patient problems
- No Clinical Signs, Symptoms or Conditions2,981
- Fibrosis2,732
- Pain1,724
- Unspecified Infection1,016
- Tissue Damage974
- Inflammation523
- Hemorrhage/Blood Loss/Bleeding362
- Swelling/ Edema298
Recent adverse event reports
The 25 most recent of 7,690 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 50921880 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921535 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920635 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50920094 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919889 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919839 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919586 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918415 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50826613 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50826515 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50825324 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli
MAUDE report 50824984 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2019 in ADA 19. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. 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 50824564 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50824406 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted(b)(6)2026 in ADA 15. Details of surgery: Implant surface not completely covered with bone and Sinus augmentation. On(b)(6)2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility and Increased Sensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hyperresponsive to stimuli
MAUDE report 50824038 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50807756 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 45. 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 50807197 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807155 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50807037 ↗InjurySep 17, 2026Difficult to Insert
The clinician reports that the day the implant was placed in the patient's mouth, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with 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 50806936 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in ADA 26. Details of surgery: Sinus augmentation. On (b)(6)2026, non-osseointegration was verified. Patient presented with fair oral hygiene and bruxism. 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 50806826 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6) 2017 in ADA 14. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III and previous bone augmentation. 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 50806527 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection
MAUDE report 50760932 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50760809 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760424 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.