Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TL (REF 043.417S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 3.3mm NNC, 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 dental implant is placed in the jaw. Its 703 reports, all listing injuries and no deaths, mostly describe the implant failing to fuse with the jawbone or losing that bond, with some mentioning fibrosis, pain and infection. Recent reports describe loss of osseointegration, with some involving peri-implantitis, pain, mobility or bleeding. 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
- 706
- Deaths reported
- 0
- Injuries reported
- 706
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 706 adverse event reports that list this exact device (DI 07630031719065), received between Aug 28, 2019 and Sep 28, 2026 — classified as 706 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (503 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 Osseointegrate503
- Loss of Osseointegration174
- Adverse Event Without Identified Device or Use Problem20
- Fracture6
- Difficult to Insert5
- Unintended Movement2
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions333
- Fibrosis195
- Pain130
- Unspecified Infection108
- Tissue Damage81
- Inflammation57
- Hemorrhage/Blood Loss/Bleeding46
- Swelling/ Edema33
Recent adverse event reports
The 25 most recent of 706 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920041 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919460 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760729 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2020 in the patient's mouth. On (B)(6) 2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50480869 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 28. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. 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 50415995 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain; Swelling/ Edema
MAUDE report 50415199 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413518 ↗InjuryAug 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2025(b)(6) in the patient's mouth. On 2026(b)(6), loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50259591 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 42. On (b)(6) 2026, 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 50258850 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 50238367 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Unspecified Infection
MAUDE report 50119353 ↗InjuryAug 3, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50119231 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2016 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102898 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2025 in the patient's mouth. On (b)(6)2026, non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50041811 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2024 in the patient's mouth. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040360 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2025 in FDI 13. On (B)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50023512 ↗InjuryJul 16, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 15. ON (B)(6) 2026, 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 25844702 ↗InjuryJul 16, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 31. 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 25844483 ↗InjuryJul 9, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 13. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25768235 ↗InjuryJul 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, 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 25693990 ↗InjuryJun 22, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25581920 ↗InjuryJun 18, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, 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 25550363 ↗InjuryJun 11, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 12. ON (B)(6) 2026, 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 25474915 ↗InjuryJun 11, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 11. ON (B)(6) 2026, 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 25474888 ↗InjuryJun 8, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 27. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25434673 ↗
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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