BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2940347 · Received February 3, 2013

    Report

    Report Number
    1030489-2013-00351
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 11, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE DAMAGES OBSERVED ARE CONSISTENT WITH A FATIGUE DAMAGING OF THE METAL DUE TO REPEATED FLEXURAL LOADING OF THE MAS. THE ORIGIN OF THE BREAKAGE MAY BE ATTRIBUTED TO THE LACK OF ANTERIOR SUPPORT COMBINED WITH PSEUDARTHROSIS (LAST SURGERY IN 2009).

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY. AT AN UNKNOWN TIME POST-OP, IT WAS DISCOVERED THAT THE SCREW AT S1 ON THE LEFT SIDE WAS BROKEN. THE SCREW SHAFT REMAINED IN THE VERTEBRA. A REVISION WAS DONE TO REPLACE THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45735 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. W05A2280

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR