BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5562511 · Received April 8, 2016

    Report

    Report Number
    1030489-2016-01041
    Event Type
    Injury
    Date Received
    April 8, 2016
    Report Date
    June 27, 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: OPTICAL AND MICROSCOPIC EXAMINATION OF THE SET SCREW WITNESS MARKS ON THE ASSOCIATED ROD IDENTIFIED ASYMMETRICAL WITNESS MARKS, AND LOCALIZED ROD WEAR AROUND THE ASYMMETRICAL WITNESS MARKS, CONSISTENT WITH CYCLIC MOVEMENT OF THE FAS SADDLE. ADDITIONALLY, ONE OF THE FOUR RETURNED FAS SADDLES WERE NOTED WITH LOCALIZED WEAR, CONSISTENT WITH THE AFOREMENTIONED CYCLIC MOVEMENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH INCOMPLETE OR ANGULATED ROD AT FINAL TIGHTENING, WHICH COULD CONTRIBUTE TO SUBSEQUENT SCREW BACK OUT.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG NUMBER 7640020 AND 510K # K052187 IS APPROVED FOR SALE IN US. (B)(4) (REVISION SURGERY). NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION AT LEVELS TH12/L2 .POST OP, A SET SCREW AT UNKNOWN LEVEL BACKED OUT. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217276 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention