Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.7510)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.8mm RC, 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 SLA Roxolid Bone Level implant has 19,941 adverse event reports in the FDA database, all of them injuries, and no deaths. Most reports describe the implant not bonding with the bone, and some describe the bond being lost later or the implant moving. Listed patient problems include pain, infection, and inflammation. 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
- 20,104
- Deaths reported
- 0
- Injuries reported
- 20,104
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20,104 adverse event reports that list this exact device (DI 07630031707543), received between Sep 9, 2019 and Sep 28, 2026 — classified as 20,104 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13,908 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 Osseointegrate13,908
- Loss of Osseointegration4,519
- Adverse Event Without Identified Device or Use Problem1,407
- Difficult to Insert231
- Separation Failure44
- Fracture36
- Unintended Movement14
- Unstable11
Patient problems
- No Clinical Signs, Symptoms or Conditions7,644
- Fibrosis7,039
- Pain4,759
- Unspecified Infection3,197
- Tissue Damage1,716
- Inflammation1,542
- Swelling/ Edema1,147
- Hemorrhage/Blood Loss/Bleeding995
Recent adverse event reports
The 25 most recent of 20,104 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921973 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921875 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Swelling/ Edema
MAUDE report 50921675 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 31. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III and previous bone augmentation. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50921633 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Numbness; Pain
MAUDE report 50921626 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921620 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921567 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921560 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50921558 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921556 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921514 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema
MAUDE report 50921499 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli; Pain; Unspecified Infection
MAUDE report 50921498 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921492 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 50921105 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920800 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920621 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50920491 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50920486 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50920458 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920429 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli; Inflammation; Unspecified Infection
MAUDE report 50920333 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920326 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920177 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation
MAUDE report 50920097 ↗
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-2535-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512
- Z-2534-2016 · Jul 14, 2016 · TerminatedStraumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
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