BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER / MAKO / 2KM CAGE 1

    MDR report key: 17450691 · Received August 2, 2023

    Report

    Report Number
    MW5120510
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 27, 2023
    Report Date
    July 31, 2023
    Manufacturer
    K2M / STRYKER SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLNT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120511 AND MW5120512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772400 STRYKER / MAKO / 2KM CAGE 1 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ K2M / STRYKER SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention CERVICAL PLATE.| SCREWS.