BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9122134 · Received September 26, 2019

    Report

    Report Number
    1030489-2019-01068
    Event Type
    Injury
    Date Received
    September 26, 2019
    Report Date
    September 26, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    UDI-DI
    00613994143181
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION (PLF) AT L4-5-S1 DUE TO SYMPTOMS OCCURRED TO L5. POST-OP, SET SCREW LOOSENED. IT WAS ASSUMED THAT THE SET SCREW WAS LOOSENED BEFORE BONE UNION OF POSTERIOR LUMBAR FUSION (PLF) WAS COMPLETED. WHILE USING THE ELECTRIC KNIFE TO PERFORM THE REVISION SURGERY, SPARKS FELL. DUE TO LOOSENING OF THE SET SCREW SEVERE METALLOSIS OCCURED NEAR THE RIGHT SIDE OF S1. PATIENT SUFFERED FROM PSEUDOARTHROSIS AT L5-S1 AND THERE WERE SOME SYMPTOMS AND COMPLICATIONS TO THE LEFT LOWER LIMBS AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918975 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11F3856 00613994143181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R