BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATING (SCP) SYSTEM

    MDR report key: 3905229 · Received July 1, 2014

    Report

    Report Number
    3005031160-2014-00007
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 30, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS DISPOSED OF POSTOPERATIVELY.

    Description of Event or Problem · 1

    THE INITIAL SURGERY WAS AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C4-5 AND C6-7 IN (B)(6) 2013. THE INITIAL SURGERY HAD BEEN SUCCESSFUL. THE PATIENT DID NOT HAVE ANY UNUSUAL PHYSIOLOGICAL OR ANATOMICAL FEATURES NOTED DURING THE INITIAL SURGERY. THE PATIENT REPORTS HAVING FOLLOWED ALL OF THE POSTOPERATIVE INSTRUCTIONS PROVIDED BY HER DOCTOR AFTER THE INITIAL SURGERY WAS COMPLETED. THEN APPROXIMATELY 1 YEAR AFTER THE ORIGINAL SURGERY, THE PATIENT DEVELOPED RECURRENT NECK PAIN AND HEADACHES, AN MRI HAD SHOWN A NEW HERNIATED NUCLEUS PULPOSUS (HNP) AT AN UNOPERATED LEVEL (C5-6). DURING THE COURSE OF THE IMAGING AND WORKUP, A POSSIBLE C6-7 PSEUDOARTHROSIS WAS IDENTIFIED, THE SURGEON DECIDED TO EXPLORE THIS LEVEL AT THE TIME OF THE REVISION SURGERY. THE SURGEON HAD DISCOVERED THAT THE SCREWS AT C6 WERE FRACTURED AFTER HE HAD PULLED THEM OUT OF THE VERTEBRAL BODY, DURING THE REVISION SURGERY. THE SURGEON DID NOT KNOW THAT THE SCREWS AT C6 WERE FRACTURED PRIOR TO PULLING THEM OUT OF THE VERTEBRAL BODY. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY FURTHER ISSUES OR DELAYS. THE PATIENT DID NOT SUSTAIN ANY INJURIES RESULTING FROM THE INITIAL SURGERY. THE PATIENT DID NOT SUSTAIN ANY INJURIES RESULTING FROM THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382707 SPIDER CERVICAL PLATING (SCP) SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY, CERVICAL KWQ X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1