BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3132362 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01889
    Event Type
    Injury
    Date Received
    May 29, 2013
    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 3 LATERAL VIEWS OF LUMBAR SPINE. IMAGES SHOW ADVANCED DEGENERATIVE DISEASE AT L5/S1 AND GRADE I SPONDYLOLISTHESIS AT L4/5 PRE-OP. POST-OP L4/5 PEDICLE SCREWS WITH INTERBODY SEEN. NO EVIDENCE OF SCREW MALFUNCTION. FINAL FILMS SHOW EXTENSION AND REVISION L4-L5-S1 WITH LARGE HARMS CAGE NOW AT L4. NO INSTRUMENT FAILURE SEEN AT ANY LEVEL.

    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
    235581 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