BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUMA

    MDR report key: 5394155 · Received January 27, 2016

    Report

    Report Number
    2032593-2016-00006
    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

    THE ALIF CONSTRUCT CONSISTED OF AN ANTERIOR PLATE AND FOUR BONE SCREWS. THERE WERE TWO LOTS RECORDED DURING THE INITIAL SURGERY. IT IS UNKNOWN WHICH LOT (S) FRACTURED. REVIEW OF THE DHRS (P809106A, AA321018A -DOCUMENTED IN 2032593-2016-00007) NOTED THAT THE PRODUCTS WERE INSPECTED AND ACCEPTED FOR USE BY THE QUALITY CONTROL DEPARTMENT ON 10-29-2008 AND 09-02-2008 RESPECTIVELY AND MET ALL SPECIFIED PARAMETERS OF THE RECEIVING INSPECTION REPORT WITH NO MATERIAL NON-CONFORMANCES OR MANUFACTURING ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. THE IMPLANTS REMAIN IN-SITU, AND NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS TIME. THE DEVICE HAS BEEN IMPLANTED FOR 21 MONTHS. REVIEW OF LABELING NOTES: WARNING, CAUTIONS AND PRECAUTIONS: "NONUNION OR PSEUDOARTHROSIS, POSSIBLY REQUIRING FURTHER SURGERY." "IMPLANTS ARE SUBJECT TO REPEATED STRESSES IN USE, AND THEIR STRENGTH IS LIMITED BY THE SIZE AND SHAPE OF THE HUMAN SPINE." "LOOSENING, BENDING, DISLOCATION, AND/OR BREAKAGE OF THE COMPONENTS, POSSIBLY REQUIRING FURTHER SURGERY" RADIOGRAPHS DEPICTING THE FRACTURE, CONFIRMED THE EVENT. PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT IS UNKNOWN. THE DEGREE OF SPINAL INSTABILITY AT S1-L5 LEVEL AND THE STABILITY OF THE ADJACENT SEGMENT (L4-L5) MOTION PRESERVATION IMPLANTATION ( PRO_DISC) IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT COMPLIED WITH POST-OPERATIVE CARE INSTRUCTIONS OR SUSTAINED A FALL/IMPACT OF SOME SORT. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THIS IS 2 OF 3 REPORTS. OTHER MTG REPORTS: 2032593-2016-00005 / 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
    53806 ZUMA INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD SEASPINE INC. P809106A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR