SCARLET® AL-T Intervertebral body fusion device SCA-LM 20 16-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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640185342071), received between Dec 4, 2024 and Jan 17, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Abdominal Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, WE RECEIVED A COMPLAINT FROM THE FIELD ((B)(6)), FROM CLINICAL STUDIES, (SEE (B)(4) FOLDER) REPORTING THAT, AROUND 7 MONTHS POSTOPERATIVE, THE PATIENT SUFFERED FROM AN ABDOMINAL WALL EVENTRATION. THE SITE CLASSIFIED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE. THE PATIENT UNDERWENT A PARIETAL REPAIR SURGERY ON (B)(6) 2024. THE PATIENT IS DOING FINE. WE REPORT THIS CASE BECAUSE A DEVICE MARKETED IN THE US IN INVOLVED.
Patient problems: Abdominal Pain
MAUDE report 21178699 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, WE RECEIVED AN UPDATED COMPLAINT FROM THE FIELD, FROM CLINICAL STUDIES, (B)(4) REPORTING THAT, FOLLOWING A SURGERY REALIZED ON (B)(6) 2023 (ALIF - L5S1 - (B)(6), - ALIF - L4L5 - (B)(6), TDR - L3L4 - PRODISC L), THE PATIENT SUFFERED FROM AN ABDOMINAL WALL EVENTRATION WHICH STARTED ON (B)(6) 2024 (AROUND 3 MONTHS PO) AND WAS CONSIDERED AS AN ADE AS PER SITE AND SPONSOR ASSESSMENT (RELATIONSHIP TO PROCEDURE) WITH MODERATE SEVERITY. A RE-INTERVENTION WAS DECIDED, AND A PARIETAL REPAIR SURGERY WAS REALIZED ON (B)(6) 2024. THE EVENT WAS CLASSIFIED AS RESOLVED ON (B)(6) 2024. AS PER SITE, THE EVENT IS NOT RELATED TO STUDY DEVICE OR TO A "DEVICE" INSTRUMENT, BUT POSSIBLY RELATED TO THE PROCEDURE. THIS AE IS NOT ASSOCIATED WITH A DEVICE DEFICIENCY. WE REPORT THIS CASE BECAUSE A DEVICE MARKETED IN THE US IN INVOLVED.
Patient problems: Abdominal Pain
MAUDE report 20843059 ↗
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.
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