BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERAMENT BONE VOID FILLER

    MDR report key: 13018899 · Received December 15, 2021

    Report

    Report Number
    MW5106077
    Event Type
    Death
    Date Received
    December 15, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BONE SUPPORT AB
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A (B)(6) Y/O ASA CLASS 1 PATIENT UNDERGOING HIP REVISION EXPERIENCED A CARDIAC COLLAPSE WITH DEATH WITHIN 2-5 MINUTES OF INJECTION OF CERAMENT BONE VOID FILLER, MANUFACTURER CERAMENT. CATALOG NUMBER A0210-11, LOT NUMBER MLOT0742, EXPIRATION DATE 06/30/2024. MICROSCOPIC AUTOPSY EXAMINATION CONCLUDE THE CAUSE OF DEATH AS: EXTENSIVE PULMONARY MICRO-EMBOLI OF FOREIGN MATERIAL CONSISTENT WITH CERAMENT BONE VOID FILLER MATERIAL. NO FAT EMBOLI WERE IDENTIFIED. FOREIGN MATERIAL CONSISTENT WITH CERAMENT BONE VOID FILLER MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913158 CERAMENT BONE VOID FILLER FILLER, BONE VOID, CALCIUM COMPOUND MQV BONE SUPPORT AB MLOT0742

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death