BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON

    MDR report key: 25209925 · Received May 18, 2026

    Report

    Report Number
    2210968-2026-05496
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    July 12, 2024
    Report Date
    May 18, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: DOI: 10.3171/2024.7.FOCUS24379. PMID: 39666345. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:JEAN WC, CHARBEL FT, COHEN-GADOL AA, COULDWELL WT, LAWTON MT, MCDERMOTT M, MORCOS JJ, SPETZLER RF, VAN LOVEREN HR; COLLABORATORS. COMPLICATIONS: SKULL BASE AND CEREBROVASCULAR. NEUROSURG FOCUS. 2024 OCT 1;57(4):E2. DOI: 10.3171/2024.7.FOCUS24379. PMID: 39666345. A 66-YEAR-OLD WOMAN PRESENTED WITH PROGRESSIVE CONFUSION, GAIT DIFFICULTIES, AND RIGHT-SIDED HEARING LOSS. MRI DEMONSTRATED A LARGE, RIGHT-SIDED KOOS GRADE IV VESTIBULAR SCHWANNOMA. THERE WAS AN ELEMENT OF HYDROCEPHALUS VISIBLE. BECAUSE OF THE PATIENT¿S INCREASING SYMPTOMS, THE DECISION WAS MADE TO UNDERTAKE SURGERY FOR TUMOR RESECTION DESPITE THE POTENTIAL FOR HEMORRHAGE, ISCHEMIC STROKE, ADDITIONAL CRANIAL NERVE DEFICIT, AND INFECTION. IT WAS THOUGHT THAT THE PATIENT MIGHT REQUIRE A VENTRICULOPERITONEAL SHUNT AFTER SURGERY IN ADDITION TO TUMOR RESECTION, SO ASSESSMENT OF THIS WAS PLANNED FOR AFTER SURGERY. THE DURA OVERLYING THE SIGMOID SINUS WAS NOTED TO BE DESICCATED AT THIS LOCATION WHEN EXPOSED WITH OPENING. THE DURA WAS CLOSED IN AN INTERRUPTED FASHION USING NUROLON SUTURE (JOHNSON & JOHNSON), MEDPOR CRANIOPLASTY (STRYKER) WAS USED TO COVER THE DEFECT, AND THE SCALP WAS CLOSED. THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATION: NUROLON SUTURE (ETHICON): (N=?) 66-YEAR-OLD WOMAN PATIENT HAD THROMBOSED SIGMOID AND TRANSVERSE SINUS WAS OBSERVED ON THE IPSILATERAL SIDE. THIS WAS THOUGHT TO BE A CONSEQUENCE OF THE DESICCATED SINUS AND POTENTIALLY INJURING THE SINUS DURING SUTURING. TREATMENT: AS A RESULT, WE BEGAN TO ADMINISTER A DAILY DOSE OF ASPIRIN (325 MG), IN ADDITION TO MAINTAINING PATIENT HYDRATION. ON POSTOPERATIVE DAY 4, THERE WAS INCREASING EDEMA IN THE CEREBELLAR PEDUNCLE AND A DEVELOPING VENOUS INFARCTION. ANTICOAGULATION TREATMENT WITH A HEPARIN DRIP WAS INITIATED AND ESCALATED GRADUALLY TO FULL ANTICOAGULATION OVER SEVERAL HOURS. ON POSTOPERATIVE DAY 5, THERE WAS ACUTE NEUROLOGICAL DECLINE, LEADING THE PATIENT TO RAPIDLY BECOME COMATOSE. AN EMERGENCY CT SCAN DEMONSTRATED HEMATOMA IN THE RESECTION CAVITY AND INVOLVING THE AREA OF VENOUS INFARCTION. THERE WAS ACUTE HYDROCEPHALUS ASSOCIATED WITH THE HEMATOMA. THE PATIENT UNDERWENT SURGICAL EVACUATION OF THE HEMATOMA, AND A VENTRICULOSTOMY WAS PERFORMED. POSTOPERATIVELY, THE PATIENT HAD AN EXTENDED COURSE IN THE INTENSIVE CARE UNIT WITH CSF DRAINAGE. SHE WAS SENT TO REHABILITATION AFTER SEVERAL WEEKS. SHE REQUIRED A PERMANENT VENTRICULOPERITONEAL SHUNT FOR HYDROCEPHALUS AND HAS PERSISTENT NEUROLOGICAL DEFICIT FROM THE HEMATOMA, INCLUDING UNSTEADY GAIT AND INCREASED FACIAL NERVE WEAKNESS (HOUSE-BRACKMANN GRADES II¿IV). WE BELIEVE THAT THE FACIAL NERVE DETERIORATION WAS A RESULT OF THE HEMATOMA AND THE RESULTANT TRAUMA TO THE FACIAL NERVE. A DELAYED POSTOPERATIVE SCAN ON DAY 60 SHOWED THE EXTENSIVE VENOUS INFARCTION IN THE CEREBELLAR PEDUNCLE AND THE VENTRICULOPERITONEAL SHUNT. IN CONCLUSION, ALTHOUGH THE VENOUS SINUS WAS NOT DOMINANT, IT WAS THE KEY DRAINAGE FOR A LARGE DRAINING VEIN THAT INVOLVED THE CEREBELLAR PEDUNCLE, WHICH BECAME THROMBOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469842 NUROLON SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1