BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3132305 · Received May 29, 2013

    Report

    Report Number
    1030489-2013-01888
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    June 12, 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

    A REVIEW OF RADIOGRAPHIC IMAGES SHOW AP AND LATERAL LUMBAR FILMS PREOP WITH DEGENERATIVE DISC DISEASE WITH OSTEOPOROSIS. PREVIOUS LAMINECTOMY IS SEEN ON THE LEFT AT L5 WITH ADVANCED FACET ARTHROPATHY AT L4 AND L5. DEGENERATIVE SPONDYLOLISTHESIS IS SEEN AT L4 GRADE II. INITIAL SURGICAL TREATMENT IS A LUMBAR DECOMPRESSION, L4/L5 POSTEROLATERAL FUSION WITH PEDICLE SCREWS. SUBSEQUENT FILMS SHOW LYSIS ABOUT THE L4 SCREWS WITH PENETRATION INTO THE L3 DISC SPACE NECESSITATING REVISION TO INCLUDE UPSIZING THE SCREWS AND ADDING A CROSSLINK TO THE CONSTRUCT. THIS SURGERY APPEARS APPROPRIATE AND REPRESENTS SIMPLE FAILURE OF BONE/IMPLANT INTERFACE TO ADEQUATELY HOLD DURING THE FUSION PROCESS.

    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 THREE VIEWS OF LUMBAR SPINE. IMAGE 1 SHOWS GRADE II SPONDYLOLISTHESIS AT L4/5 PRE-OP. IMAGE 2 SHOWS TLIF WITH PARTIAL REDUCTION OF L4/5 SPONDY. SCREW OF L4/5 WITH CAPSTONE. IMAGE 3 SHOWS REVISION TO L3-L4-L5 WITH CEMENT AUGMENTED L4 SCREWS AND GOOF REDUCTION OF SPONDY. NO EVIDENCE OF IMPLANT FAILURE SEEN ON THE FILMS.

    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
    236410 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 00073 YR