Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.3510)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 3.3mm NC, 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 is a Straumann SLA Roxolid dental implant, a tapered implant. Its reports mostly describe implants that failed to fuse with the bone, with some mentioning pain, infection or tissue damage. There are 27,237 reports, with no deaths and 27,237 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
- 27,400
- Deaths reported
- 0
- Injuries reported
- 27,400
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27,400 adverse event reports that list this exact device (DI 07630031706720), received between Aug 28, 2019 and Sep 30, 2026 — classified as 27,400 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (20,019 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 Osseointegrate20,019
- Loss of Osseointegration5,909
- Adverse Event Without Identified Device or Use Problem869
- Fracture558
- Difficult to Insert112
- Separation Failure40
- Unintended Movement18
- Unstable11
Patient problems
- No Clinical Signs, Symptoms or Conditions11,221
- Fibrosis9,076
- Pain5,913
- Unspecified Infection4,424
- Tissue Damage2,064
- Inflammation2,063
- Swelling/ Edema1,596
- Hemorrhage/Blood Loss/Bleeding1,547
Recent adverse event reports
The 25 most recent of 27,400 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 13. 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 50950325 ↗InjurySep 28, 2026Fracture
Patient problems: Unspecified Infection
MAUDE report 50922028 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921996 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 42. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Swelling. No further patient complications were reported.
Patient problems: Swelling/ Edema
MAUDE report 50921960 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921883 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921882 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50921749 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50921748 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50921747 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921677 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921266 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921244 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921138 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50920702 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920616 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920614 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50920598 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920530 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920516 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920479 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920468 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920403 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50920357 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50920160 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920150 ↗
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 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
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM21,217 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