TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS SLActive Roxolid TL (REF 033.563S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.1mm RN, SLActive® 12mm, Roxolid®, Loxim™ · Class 2 · Implant
Quick summary
This Straumann SLActive dental implant is placed in the jawbone to support a replacement tooth. Most reports describe the implant failing to fuse with the bone or later losing that connection, sometimes followed by pain, infection or gum inflammation. There are 3,836 reports, including 3,836 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
- 3,851
- Deaths reported
- 0
- Injuries reported
- 3,851
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,851 adverse event reports that list this exact device (DI 07630031715982), received between Aug 29, 2019 and Sep 28, 2026 — classified as 3,851 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,479 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 Osseointegrate2,479
- Loss of Osseointegration1,204
- Adverse Event Without Identified Device or Use Problem151
- Fracture22
- Difficult to Insert11
- Unintended Movement8
- Unstable4
- Activation, Positioning or Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,676
- Fibrosis1,085
- Pain645
- Tissue Damage565
- Unspecified Infection515
- Inflammation264
- Hemorrhage/Blood Loss/Bleeding191
- Swelling/ Edema177
Recent adverse event reports
The 25 most recent of 3,851 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921573 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921568 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807838 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806542 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50760406 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760270 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759705 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759666 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759640 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50759141 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50739028 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738318 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50719123 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50719116 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654526 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654268 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653760 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2025 in FDI 45. On (B)(6) 2025, non-osseointegration was verified. Patient presented with bone type III. 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 50480811 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50480798 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2025 in FDI 24. Details of surgery: Immediate extraction site. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Swelling and Fistula. No further patient complications were reported.
Patient problems: Fistula; Pain; Swelling/ Edema
MAUDE report 50480524 ↗InjuryAug 27, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50480523 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50415289 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414529 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 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 50283930 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 25. 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 50283830 ↗
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.