BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BL (REF 021.6312)Recalls & reported problems
Institut Straumann AG · Bone Level Implant D 4.8mm RC, SLActive® 12mm, Roxolid® Loxim™ · Class 2 · Implant
All models of BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann Bone Level SLActive implant is a screw placed in the jawbone to hold a replacement tooth. Of its 1,771 reports, all filed as injuries, most describe the implant failing to fuse with the bone or later losing that bond, and some mention difficulty inserting it. Reports also mention scar-like tissue, pain, tissue damage and infection. There are no deaths reported, 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
- 1,770
- Deaths reported
- 0
- Injuries reported
- 1,770
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,770 adverse event reports that list this exact device (DI 07630031707284), received between Aug 29, 2019 and Sep 17, 2026 — classified as 1,770 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,086 reports).
1 other recall cover devices cleared under the same FDA submission (K121131); 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 Osseointegrate1,086
- Loss of Osseointegration397
- Adverse Event Without Identified Device or Use Problem237
- Difficult to Insert50
- Unstable6
- Difficult to Remove3
- Fracture3
- Activation, Positioning or Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions672
- Fibrosis430
- Pain370
- Tissue Damage331
- Unspecified Infection244
- Inflammation170
- Swelling/ Edema102
- Hemorrhage/Blood Loss/Bleeding83
Recent adverse event reports
The 25 most recent of 1,770 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Difficult to Insert
The clinician reports that the day the implant was placed in FDI 37, failure occurred upon insertion. Details of surgery: Primary stability not achieved. Patient presented with inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50807450 ↗InjurySep 9, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 47. 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: Inflammation. No further patient complications were reported.
Patient problems: Inflammation
MAUDE report 50696288 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654705 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654558 ↗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 50458453 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (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 50284323 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6) 2017 in FDI 26. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with previous bone augmentation. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50282481 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2017 in ADA 30. 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 50199431 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2023 in ADA 30. 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 50198670 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 8. 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: Infection, Pain, Swelling and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50198537 ↗InjuryAug 10, 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. At the event the patient experienced: Pain and Hypersensitivity. No further patient complications were reported.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 50198242 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2017 in ADA 30. 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 50197358 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2023 in ADA 30. 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 50197163 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 8. 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: Infection, Pain, Swelling and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50197057 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 46. On (B)(6) 2026, non-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 50119815 ↗InjuryJul 29, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 37. 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 50072636 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 16. 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 50043123 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility, Abscess and Inflammation. No further patient complications were reported.
Patient problems: Abscess; Fibrosis; Inflammation; Pain
MAUDE report 50042857 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in ADA 9. On 2026-05-21, 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 50042670 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in ADA 9. 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 50039810 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2025 in FDI 16. 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 50023340 ↗InjuryJul 16, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 17. 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 25843710 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 34. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 25801049 ↗InjuryJul 6, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 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 25723081 ↗InjuryJul 6, 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 25722255 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121131. One submission often covers many models, so check the product and lot details in each record.
- Z-0174-2015 · Sep 24, 2014 · TerminatedStraumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/
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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