MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TL (REF 043.052S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.1mm, RN, SLA 10mm, Ti · 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 SLA Titanium dental implant appears in 9,414 adverse event reports, all of them injury reports, with no deaths. The reports mostly describe implants that fail to bond with the jawbone or later lose that bond, with some mentioning peri-implantitis, looseness and bleeding. Reports in the last 12 months number 521, down from 814 the year before. 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
- 9,438
- Deaths reported
- 0
- Injuries reported
- 9,438
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9,438 adverse event reports that list this exact device (DI 07630031700926), received between Aug 28, 2019 and Sep 28, 2026 — classified as 9,438 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4,734 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
- Loss of Osseointegration4,734
- Failure to Osseointegrate4,469
- Fracture246
- Adverse Event Without Identified Device or Use Problem94
- Unintended Movement16
- Unstable9
- Difficult to Insert8
- Difficult to Remove5
Patient problems
- No Clinical Signs, Symptoms or Conditions4,393
- Fibrosis2,098
- Unspecified Infection1,812
- Tissue Damage1,498
- Pain1,461
- Hemorrhage/Blood Loss/Bleeding681
- Inflammation680
- Swelling/ Edema294
Recent adverse event reports
The 25 most recent of 9,438 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920540 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 50920328 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50807847 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2007 in FDI 31. Details of surgery: Ridge augmentation and Immediate extraction site. 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 50807846 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50807789 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50807778 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760384 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760379 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760315 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760312 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759994 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759991 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759983 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759634 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759139 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738665 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738663 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50738458 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50720234 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719978 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719938 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain
MAUDE report 50719799 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654404 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654214 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653648 ↗
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.
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