Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.5514)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.1mm RC, SLA® 14mm, Roxolid®, Loxim™ · Class 2 · Implant
Quick summary
This Straumann dental implant is a tooth-root replacement anchored in the jawbone. Most reports describe the implant not bonding with the bone, sometimes followed by pain, scar tissue or infection. There are 3,751 reports, including 3,751 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
- 3,773
- Deaths reported
- 0
- Injuries reported
- 3,773
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,773 adverse event reports that list this exact device (DI 07630031707154), received between Sep 10, 2019 and Sep 30, 2026 — classified as 3,773 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,697 reports).
2 other recalls cover devices cleared under the same FDA submission (K150938); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2,697
- Loss of Osseointegration742
- Adverse Event Without Identified Device or Use Problem284
- Difficult to Insert39
- Fracture16
- Separation Failure4
- Unintended Movement3
- Unstable3
Patient problems
- No Clinical Signs, Symptoms or Conditions1,450
- Fibrosis1,258
- Pain949
- Unspecified Infection587
- Tissue Damage348
- Inflammation320
- Swelling/ Edema205
- Hemorrhage/Blood Loss/Bleeding148
Recent adverse event reports
The 25 most recent of 3,773 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 26. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50950209 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921513 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920369 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50919761 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50825241 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50825226 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 12. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50824460 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50824342 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760832 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760481 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50758623 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757841 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection
MAUDE report 50737979 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50737889 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50720184 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50720078 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719534 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719531 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719510 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719250 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719249 ↗InjurySep 7, 2026Fracture
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection
MAUDE report 50655391 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50655093 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50655091 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654586 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150938. One submission often covers many models, so check the product and lot details in each record.
- Z-2534-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
- Z-2535-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
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.