BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER SPINE

    MDR report key: 1639102 · Received March 22, 2010

    Report

    Report Number
    MW5015239
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    January 29, 2010
    Report Date
    March 9, 2010
    Manufacturer
    STRYKER SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VITALLIUM RODS PLACED ON (B) (6) 2009 FROM T5 TO THE PELVIS FOR SPINAL STABILIZATION. ON (B) (6) 2010, THE PT WAS GETTING INTO CAR WHEN SHE FELT A SNAP AND TRANSITORY SEVERE PAIN. X-RAYS SHOW ROD FRACTURES AT THE L2 LEVEL ON THE RIGHT AND L3 LEVEL ON THE LEFT. SURGERY RECOMMENDED TO CORRECT - NOT URGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SPINE VITALLIUM ROD (60) KWP STRYKER SPINE 03822601 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other BLOCKERS# (B) (4)| POLYAXIAL SCREWS 4.5 X 30, (B) (4)| AXIAL CONNECTOR (B) (4)| 4.5 X 40MM, (B) (4)| 4.5 X 35MM, (B) (4)