Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TL (REF 043.068S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.8mm RN, SLA® 10mm, Roxolid®, Loxim™ · Class 2 · Implant
All models of Straumann Dental Implant System Roxolid SLA Impl. (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann Standard Plus implant is a root-form dental implant placed in bone. Its 3,025 adverse event reports mostly describe implants that do not fuse with the bone or later lose that bond, and some mention scar tissue, pain, infection and bleeding. The reports include no deaths and 3,025 injuries. 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
- 3,044
- Deaths reported
- 0
- Injuries reported
- 3,044
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,044 adverse event reports that list this exact device (DI 07630031718556), received between Aug 29, 2019 and Sep 28, 2026 — classified as 3,044 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,039 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. 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 Osseointegrate2,039
- Loss of Osseointegration840
- Adverse Event Without Identified Device or Use Problem134
- Difficult to Insert22
- Fracture16
- Separation Failure4
- Defective Device1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1,355
- Fibrosis937
- Pain617
- Unspecified Infection414
- Tissue Damage364
- Hemorrhage/Blood Loss/Bleeding182
- Inflammation134
- Swelling/ Edema106
Recent adverse event reports
The 25 most recent of 3,044 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Numbness; Pain
MAUDE report 50921477 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50921095 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920408 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920082 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50920078 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920073 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919697 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50919626 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50919406 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919380 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825169 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807837 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760950 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760938 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760586 ↗InjurySep 14, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 6, failure occurred upon insertion. Details of surgery: Primary stability not achieved. 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 50759671 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759079 ↗InjurySep 14, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757698 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50738278 ↗InjurySep 10, 2026Difficult to Insert
Patient problems: Fibrosis
MAUDE report 50719751 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50719650 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654530 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50653452 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli; Hypersensitivity/Allergic reaction; Pain
MAUDE report 50653431 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50652916 ↗
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 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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