Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.7508)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.8mm RC, SLA® 8mm, 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 SLA Roxolid Bone Level implant has 16,519 adverse event reports in the FDA database, all of them injuries, and no deaths. Most reports describe the implant failing to bond with the bone, and some mention failure during insertion. Listed patient problems include 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
- 16,660
- Deaths reported
- 0
- Injuries reported
- 16,660
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16,660 adverse event reports that list this exact device (DI 07630031707536), received between Aug 28, 2019 and Sep 30, 2026 — classified as 16,660 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11,871 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 Osseointegrate11,871
- Loss of Osseointegration3,973
- Adverse Event Without Identified Device or Use Problem702
- Difficult to Insert87
- Separation Failure32
- Fracture25
- Unintended Movement4
- Unstable4
Patient problems
- No Clinical Signs, Symptoms or Conditions6,629
- Fibrosis6,376
- Pain3,605
- Unspecified Infection2,427
- Inflammation1,134
- Tissue Damage1,077
- Hemorrhage/Blood Loss/Bleeding777
- Swelling/ Edema777
Recent adverse event reports
The 25 most recent of 16,660 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 17. On 2026(b)(6), 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 50950253 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 16. 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: Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation
MAUDE report 50950206 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921942 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921941 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921910 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921874 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921862 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921838 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921831 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921715 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50921713 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921551 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920949 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920728 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920673 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920665 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920619 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50920557 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50920377 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920312 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920303 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920286 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Abscess; Fibrosis; Pain; Sinus Perforation; Unspecified Infection
MAUDE report 50920144 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula
MAUDE report 50920119 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920109 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page