SCARLET® AL-T Intervertebral body fusion device SCA-LS 15 12-SRecalls & reported problems
SpineArt SA · Secured Lumbar Anterior Cage · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640178988057), received between Jun 24, 2024 and Jun 24, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 03.JUN.2024, WE RECEIVED A COMPLAINT FROM THE FIELD, FROM FRANCE, (SEE (B)(4) FOLDER) REPORTING THAT THE PATIENT UNDERWENT A SPINE SURGERY ON L4/L5 (NOT SPINEART DEVICE) AND L5/S1 (SPINEART DEVICE) ON (B)(6) 2021. BEGINNING OF (B)(6) 2021, THE PATIENT HAD CHILLS AND ABDOMINAL PAIN, PREVERTEBRAL FLUID COLLECTION IN FRONT OF L4/L5 PROSTHESIS (PRODISC-L) WAS DISCOVERED ON (B)(6) 2021. THE INTENSITY DEGREE OF THE ADVERSE EVENT WAS CLASSIFIED AS MODERATE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE PREVERTEBRAL ABSCESS. THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2021. WE REPORT THIS CASE AS THE DEVICE INVOLVED IS US MARKETED.
Patient problems: Abdominal Pain
MAUDE report 19594088 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 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