BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3142476 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02051
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TSAHTSARLIS A ET AL. COMPLICATIONS FROM MINIMALLY INVASIVE LUMBAR INTERBODY FUSION: EXPERIENCE FROM 100 PATIENTS. J CLIN NEUROSCI (2013); HTTP://DX.DOI.ORG/10.1016/J.JOCN.2012.05.055. (B)(6). DATE IMPLANTED: BETWEEN (B)(6) 2007 AND (B)(6) 2001. (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT A PROSPECTIVE OBSERVATIONAL STUDY OF 100 CONSECUTIVE PATIENTS WAS CONDUCTED TO INVESTIGATE COMPLICATIONS OCCURRING FROM MINIMALLY INVASIVE LUMBAR INTERBODY FUSION SURGERY USING AN IMAGE-GUIDED TECHNIQUE. ALL PATIENTS UNDERWENT POST-OPERATIVE CT SCAN TO ASSESS IMPLANT PLACEMENT. SCANNING WAS REPEATED AT 6 MONTHS TO ASSESS BONY FUSION. ALL PATIENTS UNDERWENT SINGLE- OR TWO-LEVEL INSTRUMENTED MINIMALLY INVASIVE FUSION AND THE MINIMUM FOLLOW-UP PERIOD WAS 6 MONTHS. EIGHTY PATIENTS UNDERWENT SINGLE SPINAL LEVEL FUSION WITH 20 PATIENTS HAVING 2-LEVEL PROCEDURES. THE DECOMPRESSION AND INTERBODY FUSION WAS PERFORMED VIA A CYLINDRICAL OPERATING TUBE WITH AN OPERATING MICROSCOPE, USING THE IGS RATHER THAN REAL-TIME FLUOROSCOPY TO GUIDE THE PLACEMENT OF THE OPERATING TUBE. INTRA-DISCAL DISTRACTION OF THE OPERATED LEVEL WAS ACHIEVED WITH LORDOTIC DISC SPACE SPREADERS AND THEN MAINTAINED BY INSERTION AND FIXATION OF A PERCUTANEOUS ROD THROUGH THE PEDICLE SCREWS ON THE SIDE CONTRALATERAL TO THE TLIF. THIS FACILITATED ENDPLATE PREPARATION AND INSERTION OF THE INTERBODY CAGE WITH THE DISC SPACE DISTRACTED. ONCE THE INTERBODY FUSION WAS COMPLETED AND ALL SCREWS INSERTED, THE SCREWS WERE COMPRESSED OVER THE INTERBODY CAGE TO PROVIDE A DEGREE OF SEGMENTAL LORDOSIS AND COMPRESSION ACROSS THE CAGE. (B)(4). A SCREW WAS DEEMED TO BE MALPOSITIONED IF THE CORTICAL BREACH WAS GREATER THAN ONE-THIRD OF THE DIAMETER OF THE SCREW, A SYSTEM THAT HAS BEEN DESCRIBED. (B)(4) WERE REPOSITIONED IMMEDIATELY AFTER END-OF-PROCEDURE SCANNING WITH THE O-ARM, BEFORE THE PROCEDURE WAS COMPLETED. THERE WERE THEREFORE (B)(4) SCREWS IN A SUBOPTIMAL POSITION POST-OPERATIVELY. NO SCREW WAS ASSOCIATED WITH A NEW NEUROLOGICAL DEFICIT BUT ONE PATIENT HAD NEW L5 RADICULAR PAIN DUE TO IMPINGEMENT BY THE TIP OF A BICORTICAL S1 SCREW UPON THE LUMBOSACRAL TRUNK ANTERIOR TO THE SACRUM. THIS SCREW WAS RE-POSITIONED AT A SUBSEQUENT PROCEDURE, WITH RESOLUTION OF THE RADICULAR PAIN. APART FROM THIS PATIENT, ALL OF THE SUBOPTIMAL PEDICLE SCREW POSITIONS WERE LATERAL PEDICLE WALL BREACHES, WHICH IS NEUROLOGICALLY SAFE AND THUS ALL WERE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244443 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention