BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 11863060 · Received May 21, 2021

    Report

    Report Number
    3002924436-2021-00015
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    November 1, 2021
    Product Code
    NPL
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE GRAFT WAS EXPLANTED AND NOT AVAILABLE FOR ANALYSIS. THE BATCH DOCUMENTATION INCLUDING THE INDIVIDUAL DONOR PROTOCOL, THE STERILIZATION CERTIFICATE AND THE IKZ AND LAL DETERMINATION WERE CHECKED. THERE WERE NO DEPARTURES NOTED DURING RECORDS RE-REVIEW. RTI SURGICAL HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF 145 SPECIFIC TO COPIOS PERICARDIUM MEMBRANES. THERE ARE NO RELATED COMPLAINTS FOR THE SAME LOT NZA18490169. ACCORDING TO RTI SURGICAL'S RECORDS RE-REVIEW SERIAL ID (B)(6) MET SPECIFICATION SP-COPIOS MEMBRANE CE "05"; ANNEX 1-1 "02".

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN AT THIS TIME IF THE GRAFT REMAINS IMPLANTED. A COMPREHENSIVE RECORDS RE-REVIEW WILL BE CONDUCTED. ONCE RESULTS ARE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON (B)(6) 2021 . IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A COPIOS® PERICARDIU MEMBRANE AND EXPERIENCED BONE LOSS AND DEHISCENCE ON TOOTH 16. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IT IS UNKNOWN AT THIS TIME IF OTHER GRAFTS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757811 COPIOS PERICARDIUM MEMBRANE DENTAL MEMRANE NPL NZA18490169

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other