BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL IMPLANTS

    MDR report key: 8027783 · Received October 26, 2018

    Report

    Report Number
    8027783
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    October 17, 2018
    Report Date
    October 26, 2018
    Manufacturer
    STRYKER SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN L4 TO S1 LUMBAR FUSION FOR GRADE 2 SPONDYLOLISTHESIS ON (B)(6) 2018. ON (B)(6) THE PT PRESENTED TO OUTPATIENT CLINIC FOR F/U WITH COMPLAINT OF PAIN AND NUMBNESS. X-RAY SHOWED THE ROD CONNECTING THE L4 TO S1 SCREWS HAD SLIPPED ON THE S1 SCREWS. THE PT WAS ADMITTED FOR RE-EXPLORATION OF THE FUSION ON (B)(6). ON (B)(6), PT HAD EXPLORATION AND PLACEMENT OF L5 PEDICLE SCREWS AND L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION WAS PERFORMED. PT DISCHARGED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851371 SPINAL IMPLANTS SPINAL IMPLANTS - RODS KWP STRYKER SPINE FROM TRAY
    851372 SPINAL IMPLANTS SPINAL IMPLANTS - SCREWS KWP STRYKER SPINE FROM TRAY

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention