Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid TL (REF 043.655S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 4.8mm WN, SLA® 6mm, 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 has 2,495 adverse event reports, with no deaths and 2,495 injuries. Most reports describe the implant losing or failing to bond with the jawbone, with patients reporting scar tissue, pain, tissue damage and infection. 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
- 2,509
- Deaths reported
- 0
- Injuries reported
- 2,509
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,509 adverse event reports that list this exact device (DI 07630031719218), received between Aug 28, 2019 and Sep 28, 2026 — classified as 2,509 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,260 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
- Loss of Osseointegration1,260
- Failure to Osseointegrate1,171
- Adverse Event Without Identified Device or Use Problem76
- Difficult to Insert7
- Unintended Movement4
- Fracture3
- Unstable3
- Difficult to Remove2
Patient problems
- Fibrosis955
- No Clinical Signs, Symptoms or Conditions945
- Pain559
- Tissue Damage349
- Unspecified Infection306
- Inflammation106
- Hemorrhage/Blood Loss/Bleeding99
- Swelling/ Edema63
Recent adverse event reports
The 25 most recent of 2,509 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50922040 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50921485 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50920315 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50919931 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50919458 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Fistula
MAUDE report 50919431 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 37. Details of surgery: Sinus augmentation and Immediate extraction site. 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: Increased Sensitivity and Inflammation. No further patient complications were reported.
Patient problems: Hyperresponsive to stimuli; Inflammation
MAUDE report 50807749 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806827 ↗InjurySep 16, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2024 in FDI 27. Details of surgery: Implant surface not completely covered with bone. 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, Peri-implantitis, Fistula and Inflammation. No further patient complications were reported.
Patient problems: Fistula; Inflammation; Unspecified Infection
MAUDE report 50792063 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760345 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50760272 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738183 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720360 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50720145 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50720096 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50719566 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50655377 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50655035 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415477 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415475 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414649 ↗InjuryAug 20, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 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 50353008 ↗InjuryAug 17, 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. At the event the patient experienced: Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50282463 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in FDI 26. 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 50282454 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2022 in FDI 16. 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 50281819 ↗
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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