BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYOPLANT ONLAY 2.5X2.5CM

    MDR report key: 9751419 · Received February 25, 2020

    Report

    Report Number
    2916714-2020-00049
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    December 12, 2019
    Report Date
    May 5, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: DEVICE - REFERENCE CODE 1067010; DEVICE NAME LYOPLANT ONLAY 2.5X2.5CM; BATCH NUMBER 218443; UDI DEVICE IDENTIFIER (B)(4); UDI PRODUCTION IDENTIFIER (B)(4); UNIT OF USE UDI-DI (B)(4); MANUFACTURING DATE 16.11.2018. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE OF OCCURRENCE: 2019.12.12; CUSTOMER: ANONYMOUS. PICTORIAL DOCUMENTATION - NO PRODUCT AVAILABLE FOR INVESTIGATION. BATCH HISTORY REVIEW - THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE - WITHOUT THE PRODUCT, AN EXACT CAUSE CANNOT BE DETERMINED AT THIS MOMENT. DUE TO THE CONSTANT MONITORING OF THE COMPLIANCE WITH OUR QUALITY STANDARDS, AS MATTERS STAND, A PRODUCTION OR MATERIAL DEFECT CAN MOST LIKELY BE EXCLUDED. THEREFORE, THE ROOT CAUSE OF THE ERROR IS MOST PROBABLY PATIENT OR USAGE RELATED. RATIONALE - NO CAUSALITY BETWEEN THE PRODUCT AND THE MENTIONED ISSUE CAN BE FOUND. AN INFECTION OF THE PATIENT THAT ALREADY EXISTED BEFORE THE SURGERY CANNOT BE EXCLUDED. CONTRAINDICATIONS AND WARNINGS CAN BE FOUND IN THE INSTRUCTIONS FOR USE (IFU). CORRECTIVE ACTION - ACCORDING TO SOP SA-DE13-M-4-2-04-000-0 (CORRECTIVE ACTION AND PREVENTIVE ACTION), A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    NO UPDATES PROVIDED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A LYOPLANT ONLAY, PER INFORMATION PROVIDED BY MEDWATCH 5092414. THE PATIENT HAD A DURA SUBSTITUTE, LYOPLANT, INITIALLY IMPLANTED FOR CHIARI DECOMPRESSION. SOMETIME LATER, THE PATIENT PRESENTED WITH SUBDURAL HYGROMAS AND SEPTIC MENINGITIS. THIS RESULTED IN THE NEED FOR HOSPITALIZATION. ADDITIONAL INFORMATION WAS NOT RECEIVED. THE ADVERSE EVENT IS FILED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213750 LYOPLANT ONLAY 2.5X2.5CM PREVIOUSLY REPORTED GXQ AESCULAP AG 1067010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization