BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5649718 · Received May 12, 2016

    Report

    Report Number
    1030489-2016-01379
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    February 19, 2016
    Report Date
    December 9, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG NUMBER 75447545 AND 510K# K042025 IS APPROVED FOR SALE IN US. PRODUCT ANALYSIS :THE HEX EDGES OF THE MAS SCREW ARE STRIPPED. THIS IS CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: FUNCTIONAL EVALUATION WITH ASSOCIATED DRIVERS AND SAMPLE DRIVER DID NOT IDENTIFY FUNCTIONAL ISSUE WITH RESPECT TO DRIVER ENGAGEMENT INTO THE MAS BONE SCREW HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR LUMBAR INTER-BODY FUSION SURGERY AT L4-L5. DURING SURGERY, LEFT L5 SCREW WAS RE-INSERTED THREE TIMES AND WHEN A SURGEON INSERTED THE SCREW THIRD TIME, THE SURGEON WAS NOT ABLE TO CONNECT A SCREW DRIVER STRAIGHT TO THE SCREW. OFF-AXIS OF THE SCREW WAS OBSERVED IN THE THIRD ATTEMPT OF INSERTION. SAME NEW PRODUCT WAS OPENED AND USED AT THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306091 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11G1508

    Patients

    Seq Age Sex Outcome Treatment
    1