BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 4213222 · Received October 2, 2014

    Report

    Report Number
    2031966-2014-00066
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    October 2, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K093319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NUVASIVE REF: (B)(4). NO RADIOGRAPHS WERE RECEIVED CONFIRMING THE EVENT. REVISION OCCURRED (B)(6) 2014 AND CURRENT LOCATION OF EXPLANTED SCREW IS UNK. NO PRODUCT INFO WAS GIVEN AND NO FURTHER EVAL OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. IT IS UNK IF THE PT SUSTAINED SOME IMPACT OR FALL. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, PT UNDERWENT A LAMINECTOMY, POSTERIOR CERVICAL FUSION AND IMPLANTATION OF A TWO LEVEL POSTERIOR CERVICAL CONSTRUCT. LEVELS TREATED ARE UNK. DURING ROUTINE F/U ON (B)(6) 2014, SEPARATION OF THE SCREW HEAD (TULIP) FROM THE CERVICAL BONE SCREW SHANK WAS NOTED. REVISION SURGERY OCCURRED ON (B)(6) 2014 AND ALL 6 SCREWS WERE REPLACED. PT IS DOING WELL POST REVISION. PT'S BONE INTEGRITY, ACTIVITY LEVEL AND COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616763 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION APP KWP NUVASIVE, INC. 7905312 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention