TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS SLActive Roxolid TL (REF 033.560S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.1mm RN, SLActive® 6mm, Roxolid®, Loxim™ · Class 2 · Implant
Quick summary
This Straumann SLActive dental implant is placed in the jawbone to support a replacement tooth. Its 4,647 adverse event reports mostly describe implants that did not fuse with the jawbone, leaving them loose and painful, with swelling and gum inflammation around the implant in some cases. The reports include no deaths and 4,647 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
- 4,684
- Deaths reported
- 0
- Injuries reported
- 4,684
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,684 adverse event reports that list this exact device (DI 07630031700872), received between Aug 29, 2019 and Sep 28, 2026 — classified as 4,684 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,677 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 Osseointegrate2,677
- Loss of Osseointegration1,882
- Adverse Event Without Identified Device or Use Problem119
- Difficult to Insert24
- Fracture6
- Unintended Movement5
- Separation Failure3
- Therapeutic or Diagnostic Output Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,845
- Fibrosis1,670
- Pain1,053
- Tissue Damage559
- Unspecified Infection532
- Inflammation263
- Hemorrhage/Blood Loss/Bleeding178
- Swelling/ Edema168
Recent adverse event reports
The 25 most recent of 4,684 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 50921800 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921448 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921436 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921363 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50921217 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50921201 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921163 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920642 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli
MAUDE report 50920583 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920542 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920418 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920323 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 50919485 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50918660 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50807681 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 37. 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 50807158 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50807126 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50807103 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50807028 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50806903 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III, fair oral hygiene, inadequate bone quality/quantity 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 50806466 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50759427 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759337 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759047 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50758561 ↗
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.