BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZAVATION LUMBAR PEDICLE SCREW

    MDR report key: 6980716 · Received October 26, 2017

    Report

    Report Number
    3008583793-2017-00015
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ZAVATION MEDICAL PRODUCTS, LLC
    Product Code
    MNH
    PMA / PMN Number
    K112484
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    L5 S1 HERNIATED DISK NEEDED FUSION- SURGERY IN (B)(6) 2016, PATIENT RETURNED TO SURGEON BECAUSE OF PAIN. THE XRAYS SHOWED THAT THE PEDICLE SCREW WAS CRACKED OR BROKEN, A EXPLORATORY SURGERY IS SCHEDULED FOR (B)(6) 2017 TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760348 ZAVATION LUMBAR PEDICLE SCREW LUMBAR PEDICLE SCREW MNH ZAVATION MEDICAL PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization