MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TL (REF 043.928S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.1mm RN, SLA® 12mm, Ti, Loxim™ · Class 2 · Implant
All models of MODIFICATION TO ITI DENTAL IMPLANT SYSTEM (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann ITI dental implant is designed to fuse with the jawbone. Its 2,684 reports mostly describe the implant failing to fuse with the bone or losing its hold on it. The reports include 2,684 injuries and no deaths. Patient problems listed include scar tissue, pain, infection and tissue damage. 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
- 2,698
- Deaths reported
- 0
- Injuries reported
- 2,698
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,698 adverse event reports that list this exact device (DI 07630031719621), received between Aug 29, 2019 and Sep 28, 2026 — classified as 2,698 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,017 reports).
1 other recall cover devices cleared under the same FDA submission (K033922); they may or may not involve this specific model.
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 Osseointegrate2,017
- Loss of Osseointegration630
- Adverse Event Without Identified Device or Use Problem35
- Fracture9
- Difficult to Insert5
- Separation Failure3
- Insufficient Device Problem Information2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1,366
- Fibrosis741
- Pain492
- Unspecified Infection349
- Tissue Damage268
- Hemorrhage/Blood Loss/Bleeding144
- Inflammation136
- Swelling/ Edema74
Recent adverse event reports
The 25 most recent of 2,698 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 50921379 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50920786 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920096 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50920017 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50920016 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761088 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759993 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759697 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50759653 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759500 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759292 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758755 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758568 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758555 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720053 ↗InjuryAug 27, 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: Infection, Peri-implantitis, Pain, Mobility and Hypersensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hypersensitivity/Allergic reaction; Pain; Unspecified Infection
MAUDE report 50481331 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 47. 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 50480979 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 45. 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 50480976 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415200 ↗InjuryAug 20, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 34. 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 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 50353050 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50259284 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 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 50239638 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239156 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in FDI 25. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On 2026 (b)(6), 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 50199235 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 12. 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 50198973 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K033922. One submission often covers many models, so check the product and lot details in each record.
- Z-1351-2012 · Mar 12, 2012 · TerminatedStraumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to p
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.
How reports and recalls are matched · Editorial policy · Report an error on this page