STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL (REF 021.7314)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 4.8mm RC, SLActive® 14mm, Roxolid®, Loxim™ · Class 2 · Implant
All models of STRAUMANN BONE LEVEL TAPERED IMPLANT (39)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann Bone Level Tapered dental implant is placed into bone to support a replacement tooth. The 942 reports mostly describe the implant not bonding with the bone, whether at placement or later, and mention scar-like tissue, pain, infections and tissue damage. The reports include no deaths and 942 injuries, and 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
- 951
- Deaths reported
- 0
- Injuries reported
- 951
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 951 adverse event reports that list this exact device (DI 07630031707468), received between Sep 9, 2019 and Sep 28, 2026 — classified as 951 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (647 reports).
2 other recalls cover devices cleared under the same FDA submission (K140878); 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 Osseointegrate647
- Adverse Event Without Identified Device or Use Problem165
- Loss of Osseointegration125
- Difficult to Insert15
- Separation Failure2
- Unintended Movement1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions424
- Fibrosis259
- Pain148
- Unspecified Infection144
- Tissue Damage106
- Inflammation58
- Hemorrhage/Blood Loss/Bleeding38
- Swelling/ Edema32
Recent adverse event reports
The 25 most recent of 951 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2021 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. No product was returned 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 50920549 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli
MAUDE report 50760500 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50759802 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 6. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility and Increased Sensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hyperresponsive to stimuli
MAUDE report 50757862 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 2. 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: Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation
MAUDE report 50757783 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738698 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50738627 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50738198 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719702 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719439 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 31. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50718681 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 17. 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. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481792 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 47. 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. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481791 ↗InjuryAug 26, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 35. Details of surgery: Primary stability not achieved. On (b)(6) 2026, loss of 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: Pain, Mobility and Swelling. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50458440 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation
MAUDE report 50415887 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation
MAUDE report 50413441 ↗InjuryAug 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. 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 50284353 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 6. 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 50282222 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 6. On 2026 (b)(6), 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 50280982 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50121001 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50120302 ↗InjuryJul 27, 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 50040662 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. 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 50010888 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50010323 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2019 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50010320 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140878. One submission often covers many models, so check the product and lot details in each record.
- Z-2935-2026 · Jul 16, 2026 · Open, ClassifiedStraumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Z-0117-2015 · Sep 19, 2014 · TerminatedStraumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or man
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