TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS SLActive Roxolid TL (REF 033.591S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.8mm RN, SLActive® 8mm, Roxolid®, Loxim™ · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann Standard Plus SLActive dental implant is placed in the jawbone. Its 2,421 reports are all injury reports, and most describe the implant not bonding with the bone or losing that bond over time. They also mention pain, infection and tissue damage, with 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
- 2,427
- Deaths reported
- 0
- Injuries reported
- 2,427
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,427 adverse event reports that list this exact device (DI 07630031700902), received between Aug 29, 2019 and Sep 29, 2026 — classified as 2,427 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,590 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 Osseointegrate1,590
- Loss of Osseointegration757
- Adverse Event Without Identified Device or Use Problem70
- Difficult to Insert17
- Separation Failure4
- Fracture3
- Unstable2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1,196
- Fibrosis756
- Pain363
- Tissue Damage248
- Unspecified Infection227
- Inflammation125
- Swelling/ Edema71
- Hemorrhage/Blood Loss/Bleeding68
Recent adverse event reports
The 25 most recent of 2,427 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2015 in FDI 36. Details of surgery: Ridge augmentation. On (b)(6)2025, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Fistula. No further patient complications were reported.
Patient problems: Fistula; Unspecified Infection
MAUDE report 50936165 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921744 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921635 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Inflammation
MAUDE report 50921416 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 17. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain, Mobility, Swelling and Hypersensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50921404 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50920538 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50919803 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919549 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807541 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50760836 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758420 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50654438 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 16. 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 50481072 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth. 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 50416398 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 16. Details of surgery: Implant surface not completely covered with bone. On (b)(6)2026 non-osseointegration was verified. Patient presented with fair oral hygiene. 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 50283897 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
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. Patient presented with inadequate bone quality/quantity. 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 50283089 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2010 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 50281824 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 46. Details of surgery: Implant surface not completely covered with bone. 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: Numbness. No further patient complications were reported.
Patient problems: Numbness
MAUDE report 50259564 ↗InjuryAug 13, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238837 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type IV. 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 50198886 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2025 in FDI 25. 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 50198870 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6) 2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. 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 50197836 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2025 (b)(6) in FDI 26. On 2026 (b)(6), loss of osseointegration was verified. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50197720 ↗InjuryAug 7, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2016 in FDI 15. 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 50179475 ↗InjuryAug 7, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 17. 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 50178988 ↗
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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