BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6088723 · Received November 9, 2016

    Report

    Report Number
    1030489-2016-03111
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 17, 2016
    Report Date
    January 20, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    K143375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST/FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED NEAR THE START OF THE THREAD, AND IS EVIDENT AROUND THE DAMAGED PORTION OF THE THREAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION AND ANTERIOR -POSTERIOR FUSION AT L4/5/6 DUE TO SPINAL CANAL STENOSIS. DURING SURGERY, THE SURGEON TRIED TO BREAK OFF THE SET SCREW BUT IT WAS SPINNING AND IT COULD NOT BE BROKEN OFF. THE SET SCREW WAS REPLACED TO COMPLETE THE FINAL TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741446 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0409993W

    Patients

    Seq Age Sex Outcome Treatment
    1