Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TL (REF 043.256S)Recalls & reported problems
Institut Straumann AG · Standard Implant, D 3.3mm 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 Roxolid SLA implant is placed into the jawbone. Most of its 960 reports describe the implant failing to fuse with the bone or losing that fusion, and some describe fractures, pain and infection. The reports mention no deaths and 960 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
- 967
- Deaths reported
- 0
- Injuries reported
- 967
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 967 adverse event reports that list this exact device (DI 07630031718938), received between Aug 29, 2019 and Sep 28, 2026 — classified as 967 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (547 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 Osseointegrate547
- Loss of Osseointegration271
- Fracture136
- Adverse Event Without Identified Device or Use Problem15
- Difficult to Insert2
- Insufficient Device Problem Information1
- Separation Failure1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions440
- Fibrosis244
- Pain210
- Tissue Damage136
- Unspecified Infection128
- Inflammation54
- Hemorrhage/Blood Loss/Bleeding51
- Failure of Implant38
Recent adverse event reports
The 25 most recent of 967 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50919534 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760273 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759117 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759104 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50720388 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655404 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50655343 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654872 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416929 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50416659 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416652 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50416311 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6)2015 in FDI 43. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50283886 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in ADA 29. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 50258758 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 29. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 50258028 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 25. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50198657 ↗InjuryAug 7, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2021 (b)(6) in the patient's mouth. On 2026 (b)(6), 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 50179691 ↗InjuryAug 6, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 34. On 2026(b)(6) non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50162834 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 24. On (b)(6)2026, non-osseointegration was verified. Patient presented with bone type IV. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50120273 ↗InjuryJul 30, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2021(b)(6) in FDI 14. 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 50089077 ↗InjuryJul 17, 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. 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 25859883 ↗InjuryJul 17, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2008 IN THE PATIENT'S MOUTH. 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: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 25859833 ↗InjuryJul 17, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2008 IN THE PATIENT'S MOUTH. 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: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 25858717 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 23. 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 25800406 ↗InjuryJul 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 22. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25721168 ↗
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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