Modulus 1921046P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517020192), received between Sep 15, 2023 and Nov 26, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE PMCF LUMBAR INTERBODY STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2023 A PATIENT UNDERWENT A ONE LEVEL EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L3/4 WITH POSTERIOR FIXATION L3 TO L4. ON (B)(6) 2023 THE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION AT L5-S1 AS WELL AS A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4/5 WITH THE POSTERIOR FIXATION EXTENDED TO L3 TO S1. ON (B)(6) 2023 THE PATIENT REPORTED DRAINAGE FROM BACK INCISION. ON (B)(6) 2023 THE PATIENT UNDERWENT A POST-OPERATIVE WOUND INFECTION IRRIGATION AND DEBRIDEMENT PROCEDURE, AND RECEIVED A PICC LINE PLACED FOR IV ANTIBIOTICS AND EVENTUALLY DISCHARGED ON (B)(6) 2023 AND CONSIDERED RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 20783851 ↗
• MalfunctionSep 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT PRESENTED FOR L5/S1 ANTERIOR LUMBAR INTERBODY FUSION ON (B)(6) 2023. THE PATIENT DEMONSTRATED DEGENERATIVE DISC DISEASE AND A BILATERAL PARS DEFECT AT THE AND NORMATIVE BONE DENSITY AT THE INDEX LEVEL. THE PATIENT HAD A MODULUS ALIF CAGE, BRIGADE ALIF PLATE AND PLATE SCREWS IMPLANTED AT L5/S1. THE INDEX PROCEDURE WAS COMPLETED WITHOUT INCIDENT AS PER THE SURGICAL TECHNIQUE. UPON FURTHER EXAMINATION OF THE PATIENTS¿ 24 HOUR POST-OPERATIVE FILMS IT WAS EVIDENT THAT THE SCREWS HAD BECOME DISLODGED FROM THE VERTEBRAL BODIES AND THE MODULUS ALIF CAGE AND BRIGADE ALIF PLATE HAD MIGRATED ANTERIORLY. THE PATIENT WAS THEN BROUGHT BACK TO THEATRE ON (B)(6) 2023, FOR REVISION SURGERY. THE PLATE AND SCREWS WERE EXPLANTED AND THE INTERBODY CAGE WAS REPOSITIONED POSTERIORLY AND INSTRUMENTED WITH INTERFIXATED SCREWS, THE PATIENT WAS THEN REPOSITIONED IN THE PRONE POSITION AND POSTERIOR PEDICLE SCREW FIXATION OF L5/S1 WAS PERFORMED. THE REVISION SURGERY WAS COMPLETED WITHOUT INCIDENT AS PER SURGICAL TECHNIQUE. HOWEVER THE PATIENT COMPLAINED OF LEG PAIN POST-OPERATIVELY AS A RESULT OF THE FAILED CONSTRUCT, AND WAS GIVEN ADJUNCTIVE PAIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757666 ↗