BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON XPEDE BONE CEMENT

    MDR report key: 8188692 · Received December 21, 2018

    Report

    Report Number
    1030489-2018-01691
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    November 20, 2018
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: CX01B, QTY: 02, LOT# 0009428041, 510K: K163032, UDI: (B)(4), PRODUCT ID: CX01A, QTY: 02, LOT# EL70084, 510K: K163032, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP ON (B)(6) 2018, ACUTE ON-CHRONIC RESPIRATORY FAILURE AND RESPIRATORY ARREST LED TO PATIENT'S DEATH. THERE WAS NO RELATIONSHIP WITH THE ANY OF THE PRODUCTS USED/IMPLANTED IN THE SURGERY.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: L5 SPINE ABLATION.

    Description of Event or Problem · 1

    DIAGNOSTIC TEST: CT WITH CONTRAST DIAGNOSTIC TEST DATE: (B)(6) 2018 DIAGNOSTIC TEST RESULT: NO PULMONARY EMBOLISM; INCREASED DISEASE; ABNORMAL SCAN DIAGNOSTIC TEST: X-RAY DIAGNOSTIC TEST DATE: (B)(6) 2018 DIAGNOSTIC TEST RESULT: R)LOBE OPACITY/PLEURAL EFFUSION POSSIBLE POST OBSTRUCTIVE INFECTION. ABNORMAL DATE AE STARTED: (B)(6) 2018.

    Description of Event or Problem · 1

    AE START DATE: (B)(6) 2018 AE DIAGNOSTIC TESTS: DIAGNOSTIC TEST: X-RAY, DIAGNOSTIC TEST RESULT: NO CHANGE FROM CT CHEST PERFORMED ON (B)(6) 2018, DIAGNOSTIC TEST DATE: (B)(6) 2018 DIAGNOSTIC TEST: CT WITH CONTRAST, DIAGNOSTIC TEST RESULT: INCREASED POST-OBSTRUCTIVE CONSOLIDATION OF THE RIGHT LUNG, DIAGNOSTIC TEST DATE: (B)(6) 2018 AE SAE: LED TO SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT THAT RESULTED IN: IN-PATIENT OR PROLONGED HOSPITALIZATION. SITE RELATEDNESS: STUDY PROCEDURE RELATED: PROBABLE IDENTIFY THE PROCEDURE: RELATIONSHIP TO ANESTHESIA SPONSOR RELATEDNESS: STUDY PROCEDURE RELATED: PROBABLE IDENTIFY THE PROCEDURE: RELATIONSHIP TO ANESTHESIA ACTION TAKEN/TREATMENT: YES.

    Description of Event or Problem · 1

    DATE AE STARTED: (B)(6) 2018 FOR THE REPORTED AE, THE PATIENT WAS GIVEN MEDICATION BUT NO SURGICAL PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028242 KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O