BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUMA

    MDR report key: 5394437 · Received January 27, 2016

    Report

    Report Number
    2032593-2016-00005
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    January 15, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SEASPINE INC.
    Product Code
    OVD
    PMA / PMN Number
    K082926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF DEFICIENCY WITH THE PEEK INTERBODY BY THE PHYSICIAN. REVIEW OF THE DHR FOR LOT AA1032510A CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE ON (B)(6) 2013-AND MET ALL SPECIFIED PARAMETERS PER THE INSPECTION CRITERIA WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC. SINCE THERE WERE NO ALLEGATIONS OF DEFICIENCY, IT WAS MANUFACTURED TO SPECIFICATIONS, AND THERE IS NO FAILURE MODE THAT RELATES/LINKS A FUNCTIONAL PEEK INTERBODY TO THE UNRELATED SCREW FRACTURES, IT WAS DETERMINED THAT THE INTERBODY IMPLANT DID NOT CAUSE OR CONTRIBUTE TO THE SCREW FRACTURES CONCURRING REPORTED IN 2032593-2016-00006 AND 2032593-2016-00007 .

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 2032593-2016-00006 AND 2032593-2016-00007. IT WAS REPORTED THAT IN THE ONE YEAR REVISION, THE SURGEON NOTICED IN THE X-RAYS THAT THE 2 CAUDAL SCREWS WERE BROKEN. THE ORIGINAL SURGERY WENT PERFECTLY AND THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE STEP BY STEP. THE CAGE REMAINS IN ITS PLACE FOR THE TIME BEING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53802 ZUMA INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD SEASPINE INC. AA1032510A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR