Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL (REF 021.3514)Recalls & reported problems
Institut Straumann AG · Bone Level Tapered Implant, D 3.3mm NC, SLA® 14mm, Roxolid®, Loxim™ · Class 2 · Implant
Quick summary
This Straumann dental implant is placed in the jawbone to support a replacement tooth. Most reports describe the implant failing to take hold in the bone, sometimes followed by pain or scar tissue around it. There are 3,576 reports, including 3,576 injuries and no deaths. 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
- 3,597
- Deaths reported
- 0
- Injuries reported
- 3,597
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,597 adverse event reports that list this exact device (DI 07630031706744), received between Sep 9, 2019 and Sep 28, 2026 — classified as 3,597 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,745 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2,745
- Loss of Osseointegration565
- Adverse Event Without Identified Device or Use Problem211
- Difficult to Insert47
- Fracture32
- Separation Failure8
- Difficult to Remove2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1,407
- Fibrosis1,163
- Pain786
- Unspecified Infection555
- Tissue Damage321
- Inflammation266
- Swelling/ Edema212
- Hemorrhage/Blood Loss/Bleeding166
Recent adverse event reports
The 25 most recent of 3,597 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921871 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921796 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921730 ↗InjurySep 28, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921108 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50920398 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50918887 ↗InjurySep 28, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918716 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain; Unspecified Infection
MAUDE report 50826387 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50824794 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50807423 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2025 in ADA 5. 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: Infection and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50806976 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in ADA 8. 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 50806390 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 5. 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: Infection and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50806307 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760530 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759651 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759479 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Abscess; Inflammation; Pain; Swelling/ Edema
MAUDE report 50759212 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758692 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757876 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 9. Details of surgery: Implant surface not completely covered with bone and Immediate extraction site. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with inadequate bone quality/quantity. 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 50757677 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738661 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and inadequate bone quality/quantity. 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 50737970 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50737935 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720170 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719587 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.