BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPLATE ZIP SYSTEM

    MDR report key: 1477158 · Received July 17, 2009

    Report

    Report Number
    2029447-2009-00002
    Event Type
    Other
    Date Received
    July 17, 2009
    Date of Event
    March 13, 2009
    Report Date
    September 16, 2009
    Manufacturer
    BIOPLATE, INC.
    Product Code
    GXN
    PMA / PMN Number
    K013050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL NUMBER - 81-3497; ADD'L CATALOG NUMBER - PZP 2-14. THREE BIOPLATE ZIP IMPLANTS WERE USED IN A CRANIOFIXATION PROCEDURE. TWO WERE SUCCESSFULLY FIXED AND THE 3RD IMPLANT'S SHAFT WAS BROKEN BY THE SURGEON. THE SURGEON ATTEMPTED TO REMOVE THE THREE ZIP IMPLANTS AND TRIED TO REUSE THE TWO THAT HAD SUCCESSFULLY FIXED. HOWEVER, THOSE ZIP SHAFTS WERE ALSO BROKEN. ONCE FIXED, ZIP IMPLANTS CANNOT BE ADJUSTED OR MANIPULATED. THE THREE ZIP IMPLANTS WERE REMOVED COMPLETELY AND THREE NEW ZIP IMPLANTS WERE USED TO SUCCESSFULLY COMPLETE THE CASE. WE BELIEVE THAT THE SURGERY WAS DELAYED (30 MINUTES ACCORDING TO THE REPORTER) DUE TO IMPROPER USE OF THE DEVICES BY THE SURGEON, AND NOT DUE TO A MFG DEFECT OR PRODUCT QUALITY ISSUE. NO SAMPLES WERE RETURNED FOR OUR EVAL. THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE EXTENDED DURATION OF THE SURGERY. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THREE ZIP IMPLANTS WERE USED DURING A CRANIOFIXATION PROCEDURE. TWO OF THE THREE IMPLANTS WERE FIXED FIRST, BUT WHEN THE 3RD IMPLANT WAS FIXED, THE SHAFT WAS BROKEN. THE SURGEON REMOVED THE THREE IMPLANTS, AND ATTEMPTED TO REUSE TWO OF THE IMPLANTS THAT HAD BEEN FIXED, BREAKING THEM IN THE PROCESS. ALL BROKEN PRODUCTS WERE REMOVED AND THREE NEW ZIP IMPLANTS WERE USED TO COMPLETE THE CASE. THIS RESULTED IN A DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLATE ZIP SYSTEM ZIP CRANIOFIXATION SYSTEM GXN BIOPLATE, INC. 81-3496 P31740508 & UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK