BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 7040730 · Received November 17, 2017

    Report

    Report Number
    1030489-2017-02351
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    May 11, 2018
    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

    THIS PRODUCT IS A PACK OF FOUR PRODUCTS WITH PART# 6430530, 510K# K143375 AND UPN (B)(4), WHICH IS AVAILABLE FOR MARKET IN THE U.S. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS: THE SET SCREW WAS REVIEWED VISUALLY AND MICROSCOPICALLY. THERE IS NO DEFORMATION NOTED TO THE NODE OF THE SET SCREW AND THERE IS A CIRCULAR WITNESS MARK ALL THE WAY AROUND THE RAISED NODE. THIS TYPE OF WITNESS MARK IS CONSISTENT WITH THE ROD CONTACTING THE FACE OF THE SET SCREW BEFORE THE NODE. THIS CONDITION IS CONSISTENT WITH THE ROD NOT BEING FULLY REDUCED BEFORE THE SET SCREW IS INSTALLED. REDUCING THE ROD WITH THE SET SCREW CAN CAUSE THE SET SCREW TO BREAK OFF EARLY THEN BACK OUT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS LEVELS TREATED: L4-5 IT WAS REPORTED THAT DURING AN X-RAY EXAM, A SET SCREW WAS FOUND TO HAVE BACKED-OUT AT RIGHT SIDE L4. PATIENT UNDERWENT A REVISION SURGERY FOR REPLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820527 CD HORIZON SOLERA SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0580186W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention