BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2191063 · Received August 4, 2011

    Report

    Report Number
    1030489-2011-01000
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PSEUDOARTHROSIS. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT T9-S1. 9 MONTHS AFTER THE PROCEDURE THE PSEUDOARTHROSIS WAS CONFIRMED. THE SECOND SURGICAL PROCEDURE WAS PERFORMED APPROXIMATELY 9 MONTHS AFTER THE INDEX SURGERY. AT THE SECOND SURGICAL PROCEDURE, ALL IMPLANTED IMPLANTS WERE EXPLANTED EXCEPT L4 AND L5 SCREWS. ONLY L4-L5-S1 (ONLY RIGHT SIDE)-ILIAC WAS REFUSED USING ANOTHER POSTERIOR FIXATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention SET SCREWS, PEDICLE SCREWS, RODS