BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3132714 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01892
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    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 2 AP VIEWS. PRE-OP SHOWS SEVERE THORACIC SCOLIOSIS, APEX RIGHT 90 DEGREE WITH APEX ABOUT T7. EXCELLENT CORRECTION ATTAINED WITH SOLERA CONSTRUCT AND PEDICLE SCREWS AT L3-T2. APPARENT ROD FRACTURE NOTED BELOW RIGHT L8 SCREW.

    Additional Manufacturer Narrative · 1

    A REVIEW OF RADIOGRAPHIC IMAGES SHOW AP AND LATERAL VIEWS SHOW A CONSTRUCT FROM L2-L5. INITIAL SURGERY WAS DONE FROM L4 TO S1 INCLUDING DECOMPRESSION AT L5. JUNCTIONAL DISEASE DEVELOPED AT L3/4 WITH RECURRENT STENOSIS REQUIRING THIS FIRST REVISION SURGERY. SEVERE DEGENERATIVE DISC DISEASE SEEN AT L3/4 WITHOUT INTERBODY SUPPORT IN INITIAL FILM. BROKEN ROD IS REPORTED AT L2/3 AND REVISION IS COMPLETED FROM L1 TO L5. DURING SECOND REVISION INTERBODY DEVICE IS ADDED AT L1/2. ROD BREAKAGE BECAME MUCH MORE LIKELY WHEN ANTERIOR COLUMN SUPPORT WAS NOT PROVIDED DURING THE FIRST REVISION.

    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 ROD WAS BROKEN. A REVISION HAS NOT BEEN SCHEDULED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236735 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other