BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPNG-1/2X1"-STRL- 20/CS

    MDR report key: 23487989 · Received November 6, 2025

    Report

    Report Number
    1060680-2025-00054
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    September 1, 2025
    Report Date
    February 3, 2026
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    00749756037402
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED VIA A MEDWATCH, "STRING CAME OFF COTTONOID OF NEURO SPONGE." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, AND IT WAS RECEIVED ON 11/5/2025. UPON INSPECTION THE ISSUE WAS CONFIRMED AS THE STRING WAS OBSERVED TO BE UNATTACHED. AN INVENTORY CHECK WAS PERFORMED ON ONE CASE OF THE FINISHED GOODS IN STOCK AND ALL WERE FOUND TO BE ACCEPTABLE. BECAUSE THIS IS A PURCHASED PART, DEROYAL DID NOT HAVE A RISK ANALYSIS TO REVIEW. A COMPLAINT TO SALES RATIO WAS CONDUCTED BETWEEN (B)(6) 2023 TO (B)(6) 2025 AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, (B)(4). THE SUPPLIER RECEIVED THE RETURN SAMPLE; HOWEVER, THE LOT WAS NOT PROVIDED WITH THE SAMPLE SO THE SPECIFIC DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. A PREVIOUS SIMILAR COMPLAINT WAS ALSO REVIEWED. DUE TO THE PREVIOUS COMPLAINT, IT WAS NOTICED THAT WHEN MATERIAL THICKNESS VARIATIONS WOULD OCCUR, THE PRODUCTION ASSOCIATES WOULD ADJUST THE HORN CLEARANCE BUT FAIL TO VERIFY IF THE ADJUSTMENT WAS WITHIN THE SPECIFIED PARAMETERS. WITHIN THE PREVIOUS COMPLAINT, CORRECTIVE ACTIONS WERE TAKEN, BUT THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE ACTIONS. ROOT CAUSE: BECAUSE THE LOT NUMBER WAS NOT PROVIDED TO CONFIRM WITH THE DEVICE HISTORY RECORD, THE SPECIFIC ROOT CAUSE WAS NOT ABLE TO BE DETERMINED, HOWEVER, WITH THE PREVIOUS COMPLAINT, A POTENTIAL ROOT CAUSE COULD BE THAT WHEN MATERIAL THICKNESS VARIATIONS WOULD OCCUR, THE PRODUCTION ASSOCIATES WOULD ADJUST THE HORN CLEARANCE BUT FAIL TO VERIFY IF THE ADJUSTMENT WAS WITHIN THE SPECIFIED PARAMETERS. CORRECTIVE AND PREVENTIVE ACTIONS: CORRECTIVE AND PREVENTIVE ACTIONS WERE TAKEN ON THE PREVIOUS COMPLAINT AND WOULD ALSO APPLY TO THIS POTENTIAL ROOT CAUSE. THIS PREVIOUS COMPLAINT NUMBER (B)(4) AND SUBMITTED WITH MDR # 1060680-2025-00004. THESE ACTIONS INCLUDED: NEW HORNS WITH WELDER TIPS THAT PROVIDE MORE STABILITY TO THE MATERIAL. ADDITIONALLY, WORK INSTRUCTIONS WERE UPDATED TO MANDATE THE VERIFICATION OF THE DISTANCE BETWEEN THE HORN AND THE ANVIL. WITH COMPLAINT SPECIFICALLY, A RETRAINING WAS CONDUCTED FOR ALL THE OPERATORS AND SUPERVISORS ON CORRECT WELD SETUP. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED VIA A MEDWATCH, "STRING CAME OFF COTTONOID OF NEURO SPONGE." DEROYAL INDUSTRIES, INC. HAS REQUESTED RETURN OF THE DEVICE BUT HAS NOT YET RECEIVED IT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER, MEDSORB DOMINICANA, S.A. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP INFORMATION WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED VIA A MEDWATCH, "STRING CAME OFF COTTONOID OF NEURO SPONGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465693 NEURO SPNG-1/2X1"-STRL- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-055 2507243 00749756037402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown