BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON

    MDR report key: 2833112 · Received November 15, 2012

    Report

    Report Number
    1030489-2012-02201
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    May 19, 2015
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # H12B2477, EXPIRATION DATE 03-26-2020; # H12E2050 EXPIRATION DATE 06-14-2020. (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE EVENT SEVERITY HAS BEEN CHANGED TO "SERIOUS" FROM "NON-SERIOUS" BECAUSE THE ADDITIONAL SURGERY WAS REQUIRED FOR THE EVENT. THE DETAILS OF THE REVISION SURGERY WERE REPORTED THAT ALL IMPLANTS WERE REMOVED AND THE FIXATION RANGE WAS REPORTED TO BE L4-L5. AS FOR THE CAUSAL RELATIONSHIP TO INTERSPINOUS DECOMPRESSION DEVICE (I.E., "RELATED"). THE PHYSICIAN ADDITIONALLY COMMENTED THAT THE INTERSPINOUS DECOMPRESSION DEVICE-PRODUCED STRESS NOT THE IMPLANT FAILURE LED TO ONSET OF SPINOUS PROCESS FRACTURE. THE PATIENT WAS WITHDRAWN FROM PMS ON (B)(6) 2012 BECAUSE THE INTERSPINOUS DECOMPRESSION DEVICE REMOVAL WAS REQUIRED. THE PHYSICIAN JUDGED INTERSPINOUS DECOMPRESSION DEVICE AS INEFFECTIVE IN THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5 TO TREAT LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE RIGHT L5 LAMINA CRACKED DURING SCREW INSERTION. IT WAS NOTED THAT THE SCREW HOLE WAS TOO LATERAL AND COULD HAVE POSSIBLY CAUSED THE CRACK. THE INSERTION ANGLE WAS CHANGED AND THE SCREW WAS INSERTED WITHOUT PROBLEMS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H12B2477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other