BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R

    MDR report key: 9196201 · Received October 16, 2019

    Report

    Report Number
    1030489-2019-01162
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS HAVE BEEN USED IN THE SURGERY: PART# C01B; LOT# 0009832519; 510K#: K041584; UDI#: (B)(4); QTY#: 1, PART#: C01A; LOT#: EL70114; 510K# :K041584; 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

    IT WAS REPORTED VIA CLINICAL STUDY THAT PATIENT UNDERWENT KYPHOPLASTY AT T12 & L3 DUE TO UNKNOWN REASON. INTRA-OP, 1.7CC CEMENT EXTRAVASATION OCCURRED TO THE SUPERIOR DISC SPACE. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989553 KYPHON HV-R CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR