BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3132581 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01891
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 30, 2012
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 SHOW 4 LATERAL VIEWS OF THE LUMBAR SPINE. IMAGE 1 PRE-OP SHOWS GRADE III SPONDYLOLISTHESIS AT L5/S1. IMAGE 2 SHOWS COMPLETE REDUCTION OF L5/S1 WITH PEDICLE SCREWS AND "POSSIBLE" INTERBODY SPACER (SIZE OF FILM TOO SMALL TO VERIFY). IMAGE 3 SHOWS LOSS OF L5 SCREW PURCHASE WITH LOSS OF CONNECTION AND PARTIAL RETURN OF SPONDY. IMAGE 4 SHOWS REVISION TO L4-L5-S1 WITH INTERBODY DEVICE NOW CLEARLY SEEN.

    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 A SCREW HAD BACKED OUT. A REVISION WAS DONE TO REPLACE THE SCREW. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235334 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR