MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT FOLLOWING A "LEFT LUMBAR 4-LUMBAR 5 MICRODISCECTOMY" ON (B)(6) 2026 WHERE THE NEUROSPONGES WERE USED, THE "PATIENT CONTINUES TO HAVE HEALING ISSUES." THE CUSTOMER REPORTED "PERSISTENT DRAINAGE, FLUID COLLECTION SUBCUTANEOUSLY AND WOUND OPENS BACK UP" AS WELL AS "ERYTHEMA ALONG INCISION SITE." THE CUSTOMER STATED, "CULTURES HAVE BEEN DONE AND NO INFECTION PRESENT." PER THE CUSTOMER, "THE PATIENT HAD TO RETURN TO SURGERY AT (B)(6) HOSPITAL ON (B)(6) 2026 FOR AN IRRIGATION AND DEBRIDEMENT OF THE WOUND" AND THAT THE "WOUND STILL HAS NOT HEALED AND NOW PATIENT WAITING TO HAVE A WOUND VAC PLACED TO ASSIST IN THE HEALING PROCESS." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING A "LEFT LUMBAR 4-LUMBAR 5 MICRODISCECTOMY" ON (B)(6) 2026 WHERE THE NEUROSPONGES WERE USED, THE "PATIENT CONTINUES TO HAVE HEALING ISSUES." THE CUSTOMER REPORTED "PERSISTENT DRAINAGE, FLUID COLLECTION SUBCUTANEOUSLY AND WOUND OPENS BACK UP" AS WELL AS "ERYTHEMA ALONG INCISION SITE."