BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5543749 · Received April 4, 2016

    Report

    Report Number
    1030489-2016-00906
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 11, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 8115539 AND 510K# K030840 IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED. 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 ON (B)(6) 2016 PATIENT UNDERWENT REVISION SURGERY DUE TO LUMBAR CANAL STENOSIS AT L2/3 AFTER PLIF SURGERY AT L3-L5. INTRA OP, THE MIDLINE NUT WAS STRIPPED DURING TIGHTENING A CROSS LINK BECAUSE A DRIVER WAS ENTERED A LITTLE OBLIQUELY TO THE MIDLINE NUT. THE SURGEON CONSIDERED THAT THE FORCE FOR THE TIGHTENING WAS APPLIED THE CROSS LINK SO IT WAS NOT REPLACED AND IT WAS LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199619 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0312528W

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR