BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASICE HELIX-T ACP SYSTEM

    MDR report key: 4092984 · Received September 4, 2014

    Report

    Report Number
    2031966-2014-00060
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 4, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K083341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NO RADIOGRAPHS OR PRODUCT WERE RECEIVED CONFIRMING THE EVENT. PLANNED REVISION DATE IS UNK. THE PLATE REMAIN IN THE PT. 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 IT WAS REPORTED THAT THE TRANSLATIONAL CERVICAL PLATE HAD FRACTURED. IMPLANTATION DATE AND DURATION TO FAILURE IS UNK. MULTIPLE ATTEMPTS TO OBTAIN INFO WERE UNSUCCESSFUL. NO PT INJURY ASSOCIATED WITH THIS EVENT. PT'S ACTIVITY LEVEL IS UNK. PT COMPLIANCE WITH POST SURGICAL INSTRUCTIONS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541582 NUVASICE HELIX-T ACP SYSTEM SPINAL INT VERT BODY FIXATION APPLIANCE KWQ NUVASIVE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1