BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3881881 · Received June 18, 2014

    Report

    Report Number
    1030489-2014-02781
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K102555
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF RADIOGRAPHIC IMAGES SHOWS CASE IN WHICH A PATIENT UNDERWENT LUMBAR FUSION WITH SOLERA IN (B)(4) 2013. SCREWS LOOSENING AND FRACTURE WERE REPORTED FOUND AT REVISION. X-RAYS, AP AND LATERAL SHOW A CONSTRUCT FROM L2 TO S1. THE L2 CONSTRUCT IS ONLY ON THE LEFT. THE SET SCREW IS NOTED TO BE BACKED OUT AT L2. NO EVIDENCE OF FRACTURED SCREWS OR RODS IS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS NOTED THAT THE PATIENT PRESENTED WITH PAIN. A REVISION WAS DONE AND IT WAS NOTED THAT TWO SET SCREWS WERE LOOSE. DURING THE REVISION, THE CONSTRUCT WAS EXTENDED AND THE IMPLANTS REPLACED. "IT WAS NOTED DURING THE REVISION THAT THE SCREW WAS LEFT IN SITU BECAUSE IT WAS FIXED IN THE BONE." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356919 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R