BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2940414 · Received February 3, 2013

    Report

    Report Number
    1030489-2013-00360
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE LOWER SURFACE OF THE SETSCREWS IS SHOWING DEFORMATION OF THE CENTRAL POINTING TIP AND WORN PERIPHERAL SURFACE, LOWER SURFACE ALMOST FULLY WORN DUE TO MULTIPLE CONTACTS WITH THE ROD. NO PRE-EXISTING DEFECT WAS FOUND ON THE RETURNED IMPLANTS WHICH COULD BE RESPONSIBLE OF THE EVENT. THE EXACT CAUSE OF THE SETSCREW LOOSENING AND ROD SLIPPAGE CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    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 DISCOVERED THAT THE RODS HAD MIGRATED AND THE SCREWS HAD BACKED OUT. A REVISION SURGERY WAS DONE TO REPLACE THE HARDWARE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45729 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H11K2160

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR