AEGIS 187155036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034136370), received between Jul 3, 2025 and Dec 9, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Migration; Migration

  STUDY NO: (B)(6). SUBJECT ID: (B)(6). EVENT DETAILS - EVENT DATE: UN OCT 2024. ALERT DATE: 02 DEC 2025. EVENT OCCURRED - COUNTRY OF EVENT: UNITED STATES. OPERATIVE LOCATION: LUMBAR. PROCEDURE: MIS. DATE OF PROCEDURE: (B)(6) 2024. LEVELS TREATED: L2-L3: YES, L3-L4:NO, L4-L5:NO, L5-S1:NO, EVENT DESCRIPTION: GRAFT SUBSIDENCE- LUMBAR. ADDITIONAL EVENT DETAILS ADVERSE EVENT TERM: GRAFT SUBSIDENCE- LUMBAR IS THIS A WORSENING OF AN EXISTING EVENT? NO. SEVERITY: MODERATE. IS THE ADVERSE EVENT SERIOUS? NO. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. OUTCOME: RECOVERED/RESOLVED. END DATE: (B)(6) 2024. DID THIS EVENT RESULT IN THE SUBJECT'S DISCONTINUATION OF THE STUDY? IF YES, COMPLETE THE STUDY DISCONTINUATION FORM.: NO INTERVENTION/TREATMENT (MARK 'NONE/OBSERVATION' OR ALL THAT APPLY.) NONE/OBSERVATION: NO DIAGNOSTIC INTERVENTION: YES. SPECIFY: FLUORO MYELOGRAM SPINAL CANAL W/LP ON (B)(6) 2024 REHABILITATION (E.G. PT/OT): NO. INJECTED MEDICATION: YES. SPECIFY: PER NOTE: CHRONIC PAIN PROVIDER GAVE HIM SOME TRIGGER POINT INJECTIONS WHICH HELPED SOME. ASPIRATION: NO. ORAL/TOPICAL MEDICATION: NO. OTHER NON-SURGICAL TREATMENT: YES. SPECIFY: PER TEL

  Patient problems: Pain

  MAUDE report 23757697 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DSS202003. CLINICAL ADVERSE EVENT RECEIVED FOR SURGICAL INTERVENTION - GRAFT SUBSIDENCE DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLE. PROCEDURE RELATED: NOT RELATED. PROCEDURE: MIS. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: L2-L3. TREATMENT/IMPACT: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION, SURGICAL INTERVENTION FOR THE STUDY SPINE SEGMENT.

  Patient problems: Insufficient Information

  MAUDE report 22393568 ↗