BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 10138373 · Received June 10, 2020

    Report

    Report Number
    3002924436-2020-00015
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 7, 2020
    Report Date
    June 10, 2020
    Product Code
    NPL
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRAFT WAS EXPLANTED THEREFORE, A COMPREHENSIVE RECORDS RE-REVIEW WAS CONDUCTED. THERE WERE NO DEPARTURES NOTED DURING RECORDS RE-REVIEW. RTI/(B)(4) HAS DISTRIBUTED A TOTAL OF (B)(4) GRAFTS SPECIFIC TO COPIOS PERICARDIUM MEMBRANES. THERE ARE NO RELATED COMPLAINTS FOR LOT NZA18491050. ACCORDING TO RECORDS RE-REVIEW COPIOS PERICARDIUM MEMBRANES MANUFACTURED FROM LOT NZA18491050 MET RTI (B)(4) SPECIFICATION SP-COPIOS MEMBRANE CE-D "05", ANNEX 1-1 "02" K 19235 SP-97200. COPIOS PERICARDIUM MEMBRANES UNDERGO A VALIDATED STERILIZATION METHOD; TUTOPLAST®, WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER PACKAGING. TO DATE, OUR INVESTIGATION INDICATES THAT THE REPORTED COMPLICATIONS ARE MORE LIKELY ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT.

    Description of Event or Problem · 1

    ON (B)(6) 2020 BONE LOSS WITH ABSCESS AND PAIN AS SYMPTOMS WERE REPORTED. ZIMMER BIOMET IS FOLLOWING UP WITH DOCTOR BY EMAIL ABOUT CONFIRMATION OF REMOVAL DATE. DURING UNCOVERING DOCTOR NOTICED THAT THE LIFTED SIDE (AUTOGRAFT AND XENOGRAFT) WAS RED AND SWOLLEN, THE SEALING CAP WAS PARTIALLY FREE. NOT OTHER IMPLANT OR MEMBRANE HAS BEEN PLACED TO COMPLETE THE PROCEDURE. DOCTOR PERFORMED SEALING OF MAXILLARY SINUS AND PATIENT HAS BEEN RESCHEDULED FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602984 COPIOS PERICARDIUM MEMBRANE BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE: NPL NPL NZA18491050

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other