BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 9748727 · Received February 25, 2020

    Report

    Report Number
    1030489-2020-00197
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 25, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# CX01A; LOT# EL70141; 510K# K102397; UDI# (B)(4); QTY# 1 PART# CX01B; LOT# 0010023931; 510K# K102397; UDI# (B)(4); QTY# 1. IT IS UNKNOWN WHICH OF THESE CEMENT HAS EXTRAVASATED. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CEMENT EXTRAVASATION WAS NOT EXTRUDED > 15 MM IT WAS REPORTED VIA CLINICAL STUDY THAT PATIENT UNDERWENT CEMENTOPLASTY (KYPHOPLASTY) SURGERY AT INFERIOR DISK SPACE. INTRA-OP, CEMENT EXTRAVASATION OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213336 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR