BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYOPLANT ONLAY 2.5X2.5CM

    MDR report key: 9820131 · Received March 11, 2020

    Report

    Report Number
    9610612-2020-00028
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    December 12, 2019
    Report Date
    May 18, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GXQ
    PMA / PMN Number
    K122791
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: DEVICE - REFERENCE CODE 1067010. DEVICE NAME LYOPLANT ONLAY 2.5X2.5CM. SERIAL NUMBER N/A. BATCH NUMBER 218443. UDI DEVICE IDENTIFIER (B)(4). UDI PRODUCTION IDENTIFIER 218443. BASIC UDI-DI N/A. UNIT OF USE UDI-DI (B)(4). MANUFACTURING DATE 16.11.2018. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE OF OCCURRENCE: (B)(6) 2019 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A LYOPLANT ONLAY, PER INFORMATION PROVIDED BY MEDWATCH 5092414. IT WAS REPORTED THAT THE PATIENT HAD A LYOPLANT GRAFT FOR CHIARI DECOMPRESSION WITH SUBSEQUENT SUBDURAL HYROMAS AND ASEPTIC MENINGITIS. IT IS REPORTED THIS WAS A SERIOUS INJURY THAT HAD THE OUTCOME OF HOSPITALIZATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL PATIENT AND REPORTER INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279344 LYOPLANT ONLAY 2.5X2.5CM DURA REPLACEMENT GXQ AESCULAP AG 1067010 218443

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O