BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2221499 · Received August 24, 2011

    Report

    Report Number
    1030489-2011-01094
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    June 22, 2011
    Report Date
    March 8, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    KWP
    PMA / PMN Number
    K040583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE 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 DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECTS HAVE BEEN IDENTIFIED ON THE IMPLANTS THAT COULD BE RESPONSIBLE OF THE EVENT. THE ROD BROKE DUE TO OVERLOAD APPLIED ON THE SPINAL CONSTRUCT. THE LIMITED WORN SURFACE DUE TO REPETITIVE CONTACTS BETWEEN THE TWO BROKEN SECTIONS OF THE ROD SUGGESTS THE ROD BROKE RECENTLY FROM THE REVISION SURGERY DATE WHICH OCCURRED ALMOST 2 YEARS POST-OPERATIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FUSION PROCEDURE T5-S1 TO TREAT KYPHOSIS SCOLIOSIS. AN UNKNOWN TIME POST-OP, ONE OF THE RODS WAS FOUND TO BE BROKEN, AND THE PATIENT HAD PSEUDOARTHROSIS AT THE LEVEL WHERE THE ROD WAS BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY 50 MONTHS POST-OP TO REMOVE AND REPLACE THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC NA W08D1148

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention