Modulus 1091348P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517849496), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LIB COMPLICATIONS STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TWO LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4/5 AND L5/S1 WITH POSTERIOR FIXATION FROM T10 TO PELVIS. DURING THE PROCEDURE A SMALL DUROTOMY WAS ENCOUNTERED AT THE RIGHT L5-S1 HEMILAMINECTOMY SITE WHICH WAS REPAIRED WITH NUROLON AND SURASEAL. (B)(6) ON (B)(6) 2022, WHEN FINAL HEMOVAC DRAIN WAS REMOVED, INCREASE DRAINAGE FROM SITE WAS NOTED AND A TESTED SAMPLE OF FLUID WAS POSITIVE FOR TAU. SKIN SURROUNDING INCISION DEVELOPED BULLAE. MIDODRINE STARTED FOR PERIOPERATIVE HYPOTENSION. STOPPED ON POD 8 WITH THE PLAN TO RESTART HOME HORMONE SUPPLEMENT. PATIENT ENDORSED HER BLOOD PRESSURE IS HIGHER WHEN TAKING SUPPLEMENTS. PATIENT PLANS TO FOLLOW UP WITH PCP REGARDING HORMONES AND BLOOD PRESSURE MEDICATION. ON (B)(6) 2022, PATIENT CALLED IN TO NEUROSURGERY ON CALL SERVICE REPORTING SMALL AREA OF DEHISCENCE W/ YELLOW DRAINAGE. PATIENT SCHEDULED TO BE SEEN IN CLINIC ON (B)(6) 2023 VISIT SMALL DEHISCENCE W/ NO DRAINAGE. TREATED WITH KEFLEX, HOME HEALTH WOUND CARE W/ SILVER ALGINATE DRESSING. (B)(6). ON (B)(6) 2023, AT 6MO PO VISIT; PATIENT

  Patient problems: Pain

  MAUDE report 21415620 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE LIB COMPLICATIONS STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A TWO LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE AT L4/5 AND L5/S1 WITH POSTERIOR FIXATION FROM T10 TO PELVIS. DURING THE PROCEDURE A SMALL DUROTOMY WAS ENCOUNTERED AT THE RIGHT L5-S1 HEMILAMINECTOMY SITE WHICH WAS REPAIRED WITH NUROLON AND SURASEAL. (B)(6). ON (B)(6) 2022 WHEN FINAL HEMOVAC DRAIN WAS REMOVED, INCREASE DRAINAGE FROM SITE WAS NOTED AND A TESTED SAMPLE OF FLUID WAS POSITIVE FOR TAU. SKIN SURROUNDING INCISION DEVELOPED BULLAE. MIDODRINE STARTED FOR PERIOPERATIVE HYPOTENSION. STOPPED ON POD 8 WITH THE PLAN TO RESTART HOME HORMONE SUPPLEMENT. PATIENT ENDORSED HER BLOOD PRESSURE IS HIGHER WHEN TAKING SUPPLEMENTS. PATIENT PLANS TO FOLLOW UP WITH PCP REGARDING HORMONES AND BLOOD PRESSURE MEDICATION. ON (B)(6) 2022 PATIENT CALLED IN TO NEUROSURGERY ON CALL SERVICE REPORTING SMALL AREA OF DEHISCENCE W/ YELLOW DRAINAGE. PATIENT SCHEDULED TO BE SEEN IN CLINIC ON (B)(6) 2023 VISIT SMALL DEHISCENCE W/ NO DRAINAGE. TREATED WITH KEFLEX, HOME HEALTH WOUND CARE W/ SILVER ALGINATE DRESSING.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 21414976 ↗