BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1033015 · Received April 22, 2008

    Report

    Report Number
    1030489-2008-00204
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    NA
    Removal / Correction Number
    1030489-122107-009-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WITH BILATERAL POSTERIOR DYNAMIC ROD FIXATION. POST-OPERATIVE STATUS WAS GOOD. BEGINNING IN 2008, THE PATIENT BEGAN EXPERIENCING LUMBAR PAIN AND SCIATICA. X-RAYS TAKEN IN 2008, REVEALED DAMAGED CABLES OF BOTH RODS. PATIENT UNDERWENT A REVISION SURGERY THE FOLLOWING MONTH, TO REMOVE AND REPLACE THE RODS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD NQP WARSAW ORTHOPEDIC INC. NA AT200610P005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention