BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2001250 · Received February 24, 2011

    Report

    Report Number
    1030489-2011-00199
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF RADIOGRAPHIC IMAGES SHOW A GRADE II SPONDY AT L5-S1 TREATED WITH INTERBODY FUSION SPACER AND SEXANT SCREWS. ONE OF THE S1 SCREWS FRACTURED. NO PRE-OP FILMS WERE PROVIDED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL SURGERY USING POSTERIOR FIXATION. AN UNKNOWN TIME POST-OP, THE PEDICLE SCREW ON THE LEFT SIDE OF S1 BROKE. A REVISION SURGERY IS PLANNED TO REMOVE AND REPLACE THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention