BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5446557 · Received February 19, 2016

    Report

    Report Number
    1030489-2016-00501
    Event Type
    Injury
    Date Received
    February 19, 2016
    Date of Event
    January 10, 2016
    Report Date
    April 18, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE-H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL AND OPTICAL EXAMINATION OF CONFIRM ROD BREAKAGE. OPTICAL EXAMINATION SOME SECONDARY (POST-FRACTURE) DAMAGE TO THE FRACTURE SURFACE. UNDAMAGED AREAS OF FRACTURE SURFACE REVEALED RATCHET MARKS NEAR THE AREA OF CRACK PROPAGATION AND CONVEX STRIATIONS, CONSISTENT WITH CYCLIC FATIGUE. DIMENSIONAL EXAMINATION OF THE ROD DIAMETER VERIFIED CONFORMANCE TO PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #848-011, 510K # K993810 WAS CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PATIENT UNDERWENT SURGERY. POST-OP, GROWING ROD WAS BROKEN AND REVISION SURGERY WAS SCHEDULED TO REPLACE THE ROD. THE SURGEON COMMENTED THAT ALTHOUGH HE DISSUADED THE PATIENT FROM PLAYING SOCCER, THE PATIENT DID AND BREAKAGE OF ROD WAS OBSERVED MANY TIMES. HE ALSO COMMENTED THAT HE WILL PERFORM REPLACEMENT OF L4 TO S4 AT REVISION SURGERY. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATION WAS REPORTED IN THE COMPLAINT FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104471 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention